Clinical trial NCT00189202: Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
Official title: Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Kidney Transplantation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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 \< 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)

Primary outcomes:
measure: Cumulative One-year Acute Rejection Rates
timeFrame: 12 months
measure: One-year Graft Survival
timeFrame: 12 months
measure: One-year Patient Survival
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Post Transplant Diabetes
timeFrame: 12 months
measure: Drug-treated Dyslipidemic Syndrome
timeFrame: 12 months
measure: Blood Pressure Control
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Akinlolu Ojo, MD
role: PRINCIPAL_INVESTIGATOR
References: