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Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00248313
First received: November 2, 2005
Last updated: March 9, 2010
Last verified: November 2007
History of Changes
  Purpose

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.


Condition Intervention Phase
Kidney Disease
 Drug: Rapamune®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporin Dose Reduction With Cyclosporin Elimination in de Novo Renal Allograft Recipients Receiving Rapamune

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:
  • Kidney Function at 12 months after transplantation.

Secondary Outcome Measures:
  • Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.

Estimated Enrollment: 470
Study Start Date: July 2000
Study Completion Date: October 2007
  Eligibility

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

Inclusion Criteria:

  • Age: = to ≥ 18 years.
  • End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
  • Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).

Exclusion Criteria:

  • Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
  • Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248313

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: NCT00248313     History of Changes
Other Study ID Numbers: 0468E-100479
Study First Received: November 2, 2005
Last Updated: March 9, 2010
Health Authority: European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013