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Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195468
First Posted: September 19, 2005
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 90020-090
Porto Alegre, RS, Brazil, 90035-903
Ribeirao Preto, RS, Brazil, 14048-900
Sao Jose do Rio Preto, SP, Brazil, 15015-200
Sao Paulo, SP, Brazil, 01323-001
Sao Paulo, SP, Brazil, 04038-002
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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00195468     History of Changes
Other Study ID Numbers: 0468H1-101116
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: March 8, 2011
Last Verified: December 2007

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

Additional relevant MeSH terms:
Renal Insufficiency
Graft vs Host Disease
Kidney Diseases
Urologic Diseases
Immune System Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors