Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Kidney Transplantation
• Intervention / Treatment: Drug: Sirolimus

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sirolimus, steroid avoidance arm; Thymoglobulin induction, sirolimus and no maintenance corticosteroid.	Drug: Sirolimus; Thymoglobulin induction, sirolimus and no maintenance corticosteroid; Other Names: Rapamune

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative One-year Acute Rejection Rates	To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant	12 months
One-year Graft Survival	To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival	12 months
One-year Patient Survival	To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post Transplant Diabetes	To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus	12 months
Drug-treated Dyslipidemic Syndrome	To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome	12 months
Blood Pressure Control	To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 16, 2005

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: Steroid Avoidance in A.A.