Phase 3 Completed N=49 Treatment

Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

End Stage Renal Disease · Chronic Kidney Disease

Source: ClinicalTrials.gov NCT00189202 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: Cumulative One-year Acute Rejection Rates — 7 Participants — p=0.28

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.