Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | August 2004 |
| End Date: | July 1, 2008 |
Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
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.
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.
This is an open labeled prospective trial with race matched historical controls. The
treatment group (experimental arm) will be African American de novo solitary renal transplant
recipients. The control arm will consist of race matched solitary renal transplant recipients
who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be
matched for organ source (living donor vs. cadaveric). The experimental treatment arm will
have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine,
Thymoglobulin, and only 3 doses of steroids.
treatment group (experimental arm) will be African American de novo solitary renal transplant
recipients. The control arm will consist of race matched solitary renal transplant recipients
who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be
matched for organ source (living donor vs. cadaveric). The experimental treatment arm will
have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine,
Thymoglobulin, and only 3 doses of steroids.
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 < 18 years at the time of transplantation
- Multi-organ transplant recipient
- Currently taking steroids
- White Blood Cell Count < 3,000
- Platelet count < 100,000
- Triglycerides >400mg/dL
- Cholesterol > 350 mg/dL
- Unwillingness to comply with study procedures
- Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs
(Thymoglobulin)
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