Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

NCT00189202 | Completed Phase 2 Results

• 1 other identifier: Steroid Avoidance in A.A.
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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. 1.Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
2. 2.Decreased rates of metabolic complications such as post-transplant diabetes,
3. 3.The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.

Conditions

End Stage Renal Disease; Kidney Transplantation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Incidence of Post Transplant Diabetes

  12 months

• Drug-treated Dyslipidemic Syndrome

  12 months

• Blood Pressure Control

  12 months

Study Arms (1)

Sirolimus, steroid avoidance arm

EXPERIMENTAL

Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Drug: Sirolimus

Interventions

Sirolimus DRUG

Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Also known as: Rapamune

Sirolimus, steroid avoidance arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Michigan Health Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Akinlolu Ojo, Professor of Medicine
• Organization: University of Michigan

aojo@umich.edu

734 9364890

Study Officials

• Akinlolu Ojo, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Medicine

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 27, 2018
• Results First Posted: April 5, 2017

Record last verified: 2018-02

Locations

US (1)