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Trial record 1 of 1 for:    NCT00189202
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Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

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ClinicalTrials.gov Identifier: NCT00189202
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 5, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Akinlolu Ojo, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE February 20, 2017
Results First Posted Date  ICMJE April 5, 2017
Last Update Posted Date March 27, 2018
Study Start Date  ICMJE August 2004
Actual Primary Completion Date July 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
  • Cumulative One-year Acute Rejection Rates [ Time Frame: 12 months ]
    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
  • One-year Graft Survival [ Time Frame: 12 months ]
    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
  • One-year Patient Survival [ Time Frame: 12 months ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective are: Cumulative one-year acute rejection rates, one-year graft survival and one-year patient survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
  • Incidence of Post Transplant Diabetes [ Time Frame: 12 months ]
    To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus
  • Drug-treated Dyslipidemic Syndrome [ Time Frame: 12 months ]
    To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome
  • Blood Pressure Control [ Time Frame: 12 months ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Metabolic endpoints include incidence of posttransplant diabetes mellitus, drug-treated dyslipidemic syndrome, controlled
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
Official Title  ICMJE Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease
  • Kidney Transplantation
Intervention  ICMJE Drug: Sirolimus
Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Other Name: Rapamune
Study Arms  ICMJE Experimental: Sirolimus, steroid avoidance arm
Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Intervention: Drug: Sirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2017)
49
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
35
Actual Study Completion Date  ICMJE July 1, 2008
Actual Primary Completion Date July 1, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189202
Other Study ID Numbers  ICMJE Steroid Avoidance in A.A.
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Akinlolu Ojo, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Akinlolu Ojo, MD University of Michigan
PRS Account University of Michigan
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP