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Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428064
First Posted: January 29, 2007
Last Update Posted: January 29, 2007
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
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.

Condition Intervention Phase
Renal Transplantation Drug: Sirolimus Drug: cyclosporine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Equivalence of graft survival at month 12

Secondary Outcome Measures:
  • Renal function; biopsy-confirmed acute rejection, grade of acute rejection; subject and graft survival; incidence of infection, malignancy, treatment failure, and of chronic rejection as determined by protocol biopsies; quality of life.

Estimated Enrollment: 408
Study Start Date: May 1998
Estimated Study Completion Date: June 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
  • Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion Criteria:

  • Evidence of active systemic or localized major infection at the time of initial sirolimus administration
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
  • Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
  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): NCT00428064


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00428064     History of Changes
Other Study ID Numbers: 0468H1-310
First Submitted: January 25, 2007
First Posted: January 29, 2007
Last Update Posted: January 29, 2007
Last Verified: January 2007

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

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
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
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents