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Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00519116
First received: July 27, 2007
Last updated: August 20, 2007
Last verified: August 2007
History of Changes
  Purpose

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.


Condition Intervention Phase
Kidney Transplantation
 Drug: Rapamune® (Sirolimus)
Drug: Tacrolimus
Drug: Perioperative Corticosteroids
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Calculated creatinine clearance at month 6 post transplantation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus [ Time Frame: 6 months ]

Estimated Enrollment: 150
Study Start Date: October 2000
Estimated Study Completion Date: August 2001
Intervention Details:
    Drug: Rapamune® (Sirolimus) Drug: Tacrolimus Drug: Perioperative Corticosteroids
    The corticosteroids use was left up to the investigators decision.
Detailed Description:

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after 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, living-unrelated, or living-related mismatched donor
  • Patients with a secondary transplant must have maintained a primary graft for at least 6 months

Exclusion criteria:

  • Planned antibody induction
  • Multiple organ transplants
  • History of malignancy within five years of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519116

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

No publications provided

ClinicalTrials.gov Identifier: NCT00519116     History of Changes
Other Study ID Numbers: 0468E1-100539
Study First Received: July 27, 2007
Last Updated: August 20, 2007
Health Authority: Canada: Ethics Review Committee

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 May 16, 2013