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
  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:


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 April 17, 2014