Trial Outcomes & Findings for Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy (NCT NCT01120028)

NCT ID: NCT01120028

Last Updated: 2020-04-02

Results Overview

Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

852 participants

Primary outcome timeframe

6 months post-transplantation

Results posted on

2020-04-02

Participant Flow

3C was conducted in 18 transplant centres in the UK. Recruitment took place between October 2010 and July 2013.

852 participants were randomized for a comparison of Alemtuzumab (426) and Basiliximab (426) based induction therapies. After 6-months, 394 of those participants were re-randomized to either Sirolimus (197) or Tacrolimus (197) based maintenance therapies.

Participant milestones

Participant milestones
Measure	Period 1: Alemtuzumab/Tacrolimus Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab	Period 2: Sirolimus Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL.	Period 2: Tacrolimus Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL
Period 1: Alemtuzumab or Basiliximab STARTED	426	426	0	0
Period 1: Alemtuzumab or Basiliximab COMPLETED	412	403	0	0
Period 1: Alemtuzumab or Basiliximab NOT COMPLETED	14	23	0	0
Period 2: Tacrolimus or Sirolimus STARTED	0	0	197	197
Period 2: Tacrolimus or Sirolimus COMPLETED	0	0	197	197
Period 2: Tacrolimus or Sirolimus NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Period 1: Alemtuzumab/Tacrolimus Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab	Period 2: Sirolimus Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL.	Period 2: Tacrolimus Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL
Period 1: Alemtuzumab or Basiliximab Withdrawal by Subject	0	5	0	0
Period 1: Alemtuzumab or Basiliximab Not transplanted	14	18	0	0

Baseline Characteristics

Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 1: Alemtuzumab/Tacrolimus n=426 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart. Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=426 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart. Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab.	Period 2: Sirolimus n=197 Participants Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL.	Period 2: Tacrolimus n=197 Participants Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL.	Total n=1246 Participants Total of all reporting groups
Other Previous Disease Cancer	18 participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	5 participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	23 participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Categorical Age, Period 1 · <=18 years	0 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Categorical Age, Period 1 · Between 18 and 65 years	347 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	350 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	697 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Categorical Age, Period 1 · >=65 years	79 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	76 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	155 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Categorical Age, Period 2 · <=18 years	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Categorical Age, Period 2 · Between 18 and 65 years	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	163 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	162 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	325 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Categorical Age, Period 2 · >=65 years	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	34 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	35 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	69 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Continuous Age, Continuous, Period 1	52.1 years STANDARD_DEVIATION 13.3 • n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	51.8 years STANDARD_DEVIATION 13.3 • n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	51.9 years STANDARD_DEVIATION 13.3 • n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Age, Continuous Age, Continuous, Period 2	—	—	51.7 years STANDARD_DEVIATION 13.0 • n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	52.0 years STANDARD_DEVIATION 12.9 • n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	51.8 years STANDARD_DEVIATION 13.0 • n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Sex: Female, Male Sex, Period 1 · Female	149 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	151 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	300 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Sex: Female, Male Sex, Period 1 · Male	277 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	275 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	552 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Sex: Female, Male Sex, Period 2 · Female	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	65 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	65 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	130 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Sex: Female, Male Sex, Period 2 · Male	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	132 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	132 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	264 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 1 · White	370 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	372 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	742 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 1 · Black	21 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	21 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	42 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 1 · Asian	30 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	23 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	53 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 1 · Other	5 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	10 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	15 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 2 · White	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	174 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	173 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	347 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 2 · Black	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	5 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	7 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	12 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 2 · Asian	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	13 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	15 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	28 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Race/Ethnicity, Customized Ethnic origin, Period 2 · Other	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	5 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	2 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	7 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Region of Enrollment United Kingdom · Period 1: United Kingdom	426 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	426 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	852 Participants n=1246 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Region of Enrollment United Kingdom · Period 2: United Kingdom	0 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	197 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	197 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	394 Participants n=1246 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Diabetic kidney disease	51 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	49 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	100 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Glomerulonephritis	92 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	89 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	181 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Polycystic kidney disease	68 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	73 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	141 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Chronic pyelonephritis	23 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	16 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	39 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Hypertension	42 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	42 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	84 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous renal replacement Haemodialysis	243 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	214 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	457 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Renovascular disease	7 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	6 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	13 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary Renal Disease: Period 1 · Other	143 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	151 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	294 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Diabetic kidney disease	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	15 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	21 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	36 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Glomerulonephritis	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	50 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	40 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	90 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Polycystic kidney disease	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	47 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	34 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	81 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Chronic pyelonephritis	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	5 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	9 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	14 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Hypertension	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	14 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	24 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	38 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Renovascular disease	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	3 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	4 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	7 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Primary Renal Disease Primary renal disease, Period 2 · Other	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	63 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	65 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	128 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Other Previous Disease Diabetes	74 participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	67 participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	141 participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Other Previous Disease Vascular Disease	57 participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	49 participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	106 participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous renal replacement Peritoneal dialysis	104 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	106 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	210 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous renal replacement Transplant	3 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	3 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	6 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous renal replacement None	76 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	103 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	179 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 1 · Level 1	45 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	47 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	92 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 1 · Level 2	94 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	94 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	188 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 1 · Level 3	196 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	193 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	389 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 1 · Level 4	91 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	92 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	183 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 2 · Level 1	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	23 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	22 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	45 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 2 · Level 2	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	42 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	42 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	84 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 2 · Level 3	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	89 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	90 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	179 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
HLA mismatch level HLA mismatch level, Period 2 · Level 4	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	43 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	43 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	86 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous transplant Previous transplant, Period 1 · None	390 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	392 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	782 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous transplant Previous transplant, Period 1 · ≥1	36 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	34 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	70 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous transplant Previous transplant, Period 2 · None	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	181 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	181 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	362 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Previous transplant Previous transplant, Period 2 · ≥1	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	16 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	16 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	32 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Highly sensitised Highly sensitized, Period 1 · Yes	16 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	15 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	31 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Highly sensitised Highly sensitized, Period 1 · No	410 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	411 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	821 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Highly sensitised Highly sensitized, Period 2 · Yes	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	4 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	7 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	11 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Highly sensitised Highly sensitized, Period 2 · No	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	193 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	190 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	383 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Virology serology CMV-positive donor to negative recipient	104 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	102 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	206 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Virology serology EBV-positive donor to negative recipient	21 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	19 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	40 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Type of donor Type of donor, Period 1 · Donation after brain death	148 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	145 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	293 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Type of donor Type of donor, Period 1 · Donation after circulatory death	158 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	158 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	316 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Type of donor Type of donor, Period 1 · Donation from living (related or unrelated) person	120 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	123 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	243 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Type of donor Type of donor, Period 2 · Donation after brain death	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	66 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	65 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	131 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Type of donor Type of donor, Period 2 · Donation after circulatory death	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	65 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	69 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	134 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Type of donor Type of donor, Period 2 · Donation from living (related or unrelated) person	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	66 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	63 Participants n=197 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	129 Participants n=394 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Donor sex Male	215 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	207 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	422 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Donor sex Female	193 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	179 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	372 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Donor sex Unknown	18 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	40 Participants n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	0 Participants Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	58 Participants n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Cold ischaemia time (h)	13.9 Hours STANDARD_DEVIATION 5.7 • n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	12.9 Hours STANDARD_DEVIATION 6.0 • n=426 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).	—	—	13.4 Hours STANDARD_DEVIATION 5.9 • n=852 Participants • Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).

PRIMARY outcome

Timeframe: 6 months post-transplantation

Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=426 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=426 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy	31 Participants	68 Participants

PRIMARY outcome

Timeframe: 2 years post-transplantation

Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=197 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=197 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Graft Function (at 18-months After Randomization to Maintenance Therapy)	53.7 mL/min/1.73m² Standard Error 0.9	54.6 mL/min/1.73m² Standard Error 0.9

SECONDARY outcome

Timeframe: 6 months post-transplantation

Return to dialysis or re-transplantation by 6-months after randomization to induction therapy.

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=426 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=426 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy)	16 Participants	13 Participants

SECONDARY outcome

Timeframe: 2 years post-transplantation

Return to dialysis or re-transplantation by 18-months after randomization to maintenance therapy.

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=197 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=197 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy)	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 6-months post-transplantation

Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported within Period 1 (randomization to induction therapy of either Alemtuzumab (Campath-1H) and Tacrolimus, or Basiliximab and Tacrolimus).

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=426 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=426 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy)	135 Participants	136 Participants

SECONDARY outcome

Timeframe: 2 years post-transplantation

Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus).

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=197 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=197 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy)	95 Participants	70 Participants

SECONDARY outcome

Timeframe: 2 years post-transplantation

Occurrence of any cancer reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus).

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=197 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=197 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy)	17 Participants	17 Participants

SECONDARY outcome

Timeframe: 2 years post-transplantation

Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization

Outcome measures

Outcome measures
Measure	Period 1: Alemtuzumab/Tacrolimus n=197 Participants Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.	Period 1: Basiliximab/Tacrolimus n=197 Participants Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab
Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy)	10 Participants	13 Participants

Adverse Events

Period 1: Alemtuzumab/Tacrolimus

Serious events: 341 serious events

Other events: 0 other events

Deaths: 11 deaths

Period 1: Basiliximab/Tacrolimus

Serious events: 354 serious events

Other events: 0 other events

Deaths: 6 deaths

Period 2: Sirolimus

Serious events: 140 serious events

Other events: 0 other events

Deaths: 11 deaths

Period 2: Tacrolimus

Serious events: 134 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Prof Peter Friend

University of Oxford

Phone: 01865223872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place