MedTrace Logo

Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

NCT00189202 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-03-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Sirolimus

Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Sponsors & Collaborators

Principal Investigators

  • Akinlolu Ojo, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2008-07-01
Completion
2008-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00189202 on ClinicalTrials.gov