Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00518271
First received: July 26, 2007
Last updated: August 16, 2007
Last verified: August 2007
  Purpose

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.


Condition Intervention Phase
Kidney Transplantation
Drug: Rapamune® (Sirolimus)
Drug: Tacrolimus
Drug: Corticosteroids
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.

Secondary Outcome Measures:
  • Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.

Enrollment: 120
Study Start Date: April 2000
Study Completion Date: June 2002
Intervention Details:
    Drug: Rapamune® (Sirolimus) Drug: Tacrolimus Drug: Corticosteroids
    Perioperative
Detailed Description:

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • At least 18 years of age
  • End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
  • Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

  • Planned antibody induction
  • Multiple organ transplants
  • Patients at high risk of acute rejection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518271

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00518271     History of Changes
Other Study ID Numbers: 0468E1-100193
Study First Received: July 26, 2007
Last Updated: August 16, 2007
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Sirolimus
Everolimus
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 14, 2014