Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00470665

Purpose

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

Condition	Intervention	Phase
Renal Allograft Recipients	Drug: Rapamune	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients

Further study details as provided by Wyeth:

Primary Outcome Measures:

First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.

Estimated Enrollment:	460
Study Start Date:	August 2002
Estimated Study Completion Date:	July 2004

Eligibility

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

Criteria

Inclusion criteria:

Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
Age >= 13 years, weight >= 40 kg
Women must have a negative pregnancy test at study entry

Exclusion criteria

Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
Active systemic infection, or localized major infection or known HIV
Patients with residual kidney function >20 mL/min

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470665

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Gaber AO, Kahan BD, Van Buren C, Schulman SL, Scarola J, Neylan JF; Sirolimus High-Risk Study Group. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation. 2008 Nov 15;86(9):1187-95.

Study ID Numbers:	0468H1-903
Study First Received:	May 7, 2007
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00470665 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus
Anti-Bacterial Agents
Cyclosporine
Immunologic Factors
Clotrimazole
Miconazole

Antifungal Agents
Tioconazole
Tacrolimus
Immunosuppressive Agents
Cyclosporins

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 May 07, 2009