At a glance
ClinicalIndex Comparison Record- ✓African American recipient race
- ✓Single cadaveric or living donor kidney transplant
- ✓Age ≥18 years at time of transplantation
- ✓Negative pregnancy serum test for females with childbearing potential
- ✕Multi-organ transplant recipient
- ✕Currently taking steroids at baseline
- ✕White blood cell count <3,000/μL
- ✕Platelet count <100,000/μL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
In Brief
A Phase 3 clinical trial evaluating Sirolimus for End Stage Renal Disease and Kidney Transplantation. Completed, enrolled 49 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Thymoglobulin induction, sirolimus and no maintenance corticosteroid