Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

NCT00189202

Last updated date
Study Location
University of Michigan Health Center
Ann Arbor, Michigan, 48109, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
End Stage Renal Disease, Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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End Stage Renal Disease, Kidney TransplantationEfficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
NCT00189202
  1. Ann Arbor, Michigan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDUniversity 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