Phase 3
N=49
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
End Stage Renal Disease · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00189202 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Cumulative One-year Acute Rejection Rates — 7 Participants — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative One-year Acute Rejection Rates |
7 | 0.28 |
| PRIMARY One-year Graft Survival |
42 | 0.70 |
| PRIMARY One-year Patient Survival |
44 | — |
| SECONDARY Incidence of Post Transplant Diabetes |
9 | — |
| SECONDARY Drug-treated Dyslipidemic Syndrome |
21 | — |
| SECONDARY Blood Pressure Control |
34 | — |
Summary
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.
This study will evaluate:
1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
2. Decreased rates of metabolic complications such as post-transplant diabetes,
3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.
Eligibility Criteria
Inclusion Criteria
- African American recipient race
- Solitary cadaveric or living donor renal transplantation
- Age ≥18years at the time of transplantation
- Negative pregnancy serum test in females with childbearing potential
Exclusion Criteria
- Age 400mg/dL
- Cholesterol > 350 mg/dL
- Unwillingness to comply with study procedures
- Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)
Data sourced from ClinicalTrials.gov (NCT00189202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.