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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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 Transplantation	Drug: Sirolimus Drug: tacrolimus Drug: Cyclosporine A	Phase III

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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Everolimus CCI 779

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

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 February 09, 2012