Trial Outcomes & Findings for Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab (NCT NCT01213329)

Results Overview

Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months \& 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells \& NK cells, naive \& memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). Unfortunately blood samples were lost due to malfunction of liquid nitrogen tank that stopped working during a power loss.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

Pre-transplant, 6months & 12 months post-transplant

Results posted on

2019-04-10

Participant Flow

All patients were approached pre-operatively in the transplant clinic at Northwestern Memorial Hospital. Recruitment began on July 28, 2005 and lasted until April 14, 2008.

The first year of the study was specimen collection only. Group assignment (phase 2) was intended to begin after 12months of sample collection and there were not any subjects who continued into phase 2. An additional pair enrolled compared to the number that started this study. This is due to a loss of samples from a processing inconsistency

Participant milestones

Participant milestones
Measure	Alemtuzumab (Phase I) All transplant recipients received one 30mg dose (intravenous "IV" push)of Alemtuzmab in the operating room per Standard of Care.	Donor Comparison
Screening STARTED	25	25
Screening COMPLETED	25	25
Screening NOT COMPLETED	0	0
Phase 2 STARTED	0	0
Phase 2 COMPLETED	0	0
Phase 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alemtuzumab (Phase I) n=26 Participants All transplant recipients received one 30mg dose (intravenous "IV" push)of Alemtuzmab in the operating room per Standard of Care.	Donor Comparison n=25 Participants	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 22 • n=5 Participants	43 years STANDARD_DEVIATION 9.46 • n=7 Participants	42 years STANDARD_DEVIATION 31.46 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-transplant, 6months & 12 months post-transplant

Population: samples from 26 recipient/donor pairs were collected = 52 collected but no analysis was performed because samples were lost.

Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months \& 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells \& NK cells, naive \& memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). Unfortunately blood samples were lost due to malfunction of liquid nitrogen tank that stopped working during a power loss.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-transplant, 6mo & 12mo post-transplant

Population: no one were analyzed due to loss of blood samples

Identify, by studying recipients for development of donor specific hypo-reactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized. Unfortunately this secondary outcome was not studied because of lost samples that did not allowed us further analysis to identify patients with donor specific hypo reactivity.

Outcome measures

Outcome data not reported

Adverse Events

Alemtuzumab (Phase I)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Donor Comparison

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lorenzo Gallon

Northwestern University

Phone: 312-695-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place