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Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00038948
First received: June 5, 2002
Last updated: April 22, 2010
Last verified: April 2010
History of Changes
  Purpose

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.


Condition Intervention Phase
Renal Transplantation
 Drug: Sirolimus
Drug: tacrolimus
Drug: Cyclosporine A
 Phase 3

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, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

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:
  • Nankivell Glomerular Filtration Rate (GFR) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.


Secondary Outcome Measures:
  • First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. [ Time Frame: 52 and 104 weeks ] [ Designated as safety issue: Yes ]
    Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).


Enrollment: 830
Study Start Date: January 2002
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
 Drug: Sirolimus
Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
Drug: tacrolimus Drug: Cyclosporine A
Active Comparator: B
Continued calcineurin inhibitor therapy
 Drug: Sirolimus
Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
Drug: tacrolimus Drug: Cyclosporine A

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 13 years.
  • Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
  • Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

  • Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
  • Patients in whom kidney-pancreas or other multiple organ transplants have been performed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038948

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 by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00038948     History of Changes
Other Study ID Numbers: 0468H1-316
Study First Received: June 5, 2002
Results First Received: May 29, 2009
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Renal
Allograft
Recipients

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Tacrolimus
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 23, 2013