Trial Outcomes & Findings for Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans (NCT NCT00189202)

NCT ID: NCT00189202

Last Updated: 2018-03-27

Results Overview

To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 49 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-03-27

Participant Flow

Participant milestones

Measure	Sirolimus, Steroid Avoidance Arm Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Overall Study STARTED	49
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Sirolimus, Steroid Avoidance Arm Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Overall Study Physician Decision	5

Baseline Characteristics

Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

Baseline characteristics by cohort

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Age, Continuous	46 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant

Outcome measures

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Cumulative One-year Acute Rejection Rates	7 Participants

PRIMARY outcome

Timeframe: 12 months

To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival

Outcome measures

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
One-year Graft Survival	42 Participants

PRIMARY outcome

Timeframe: 12 months

To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival

Outcome measures

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
One-year Patient Survival	44 Participants

SECONDARY outcome

Timeframe: 12 months

To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus

Outcome measures

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Incidence of Post Transplant Diabetes	9 Participants

SECONDARY outcome

Timeframe: 12 months

To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome

Outcome measures

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Drug-treated Dyslipidemic Syndrome	21 Participants

SECONDARY outcome

Timeframe: 12 months

To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication

Outcome measures

Measure	Sirolimus, Steroid Avoidance Arm n=44 Participants Thymoglobulin induction, sirolimus and no maintenance corticosteroid. Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Blood Pressure Control	34 Participants

Adverse Events

Sirolimus, Steroid Avoidance Arm

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. Akinlolu Ojo, Professor of Medicine

University of Michigan

Phone: 734 9364890

Email: aojo@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place