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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00038948

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 Allograft Recipients	Drug: Sirolimus	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Sirolimus

Further study details as provided by Wyeth:

Primary Outcome Measures:

Efficacy: To determine the effect of conversion from CI- to SRL-based therapy on renal function 52 weeks after randomization. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

equivalence 52 weeks after randomization between treatment groups in the composite endpoint of the incidence of the first occurrence of biopsy-confirmed acute rejection, graft loss, or death. [ Time Frame: 104, 156, 208 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	830
Study Start Date:	January 2002
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression	Drug: Sirolimus Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
B: Active Comparator Continued calcineurin inhibitor therapy	Drug: Sirolimus Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled

Eligibility

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

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468H1-316
Study First Received:	June 5, 2002
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00038948 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Renal
Allograft
Recipients

Additional relevant MeSH terms:

Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009