Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine 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:
NCT00195468
First received: September 13, 2005
Last updated: March 7, 2011
Last verified: December 2007
  Purpose

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).


Condition Intervention Phase
Kidney Failure
Graft vs Host Disease
Drug: CYCLOSPORINE
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: A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine 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:
  • Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

Secondary Outcome Measures:
  • Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.

Estimated Enrollment: 280
Study Start Date: March 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

Exclusion Criteria:

  • Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195468

Locations
Brazil
Curitiba, PR, Brazil, 80730-150
Rio de Janeiro, RJ, Brazil, 21041-030
Rio de Janeiro, RJ, Brazil, 21941-590
Porto Alegre, RS, Brazil, 90035-903
Porto Alegre, RS, Brazil, 90020-090
Ribeirao Preto, RS, Brazil, 14048-900
Sao Jose do Rio Preto, SP, Brazil, 15015-200
Sao Paulo, SP, Brazil, 04038-002
Sao Paulo, SP, Brazil, 01323-001
Sao Paulo, SP, Brazil, 05403-000
Mexico
Torreon, Coahuila, Mexico, 27000
Chihuahua, Mexico
Mexico City DF, Mexico, 14000
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
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezlj@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00195468     History of Changes
Other Study ID Numbers: 0468H1-101116
Study First Received: September 13, 2005
Last Updated: March 7, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Mexico: Federal Commission for Protection Against Health Risks

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

Additional relevant MeSH terms:
Graft vs Host Disease
Renal Insufficiency
Immune System Diseases
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
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

ClinicalTrials.gov processed this record on August 21, 2014