Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients - Full Text View

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 III

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Cyclosporine Cyclosporin Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Wyeth:

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

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428064

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Publications indexed to this study:

Friend P, Russ G, Oberbauer R, Murgia MG, Tufveson G, Chapman J, Blancho G, Mota A, Grandaliano G, Campistol JM, Brault Y, Burke JT; for the Rapamune Maintenance Regimen (RMR) Study Group. Incidence of anemia in sirolimus-treated renal transplant recipients: the importance of preserving renal function. Transpl Int. 2007 Sep;20(9):754-60. Epub 2007 Jun 12.

Study ID Numbers:	0468H1-310
First Received:	January 25, 2007
Last Updated:	January 26, 2007
ClinicalTrials.gov Identifier:	NCT00428064
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Renal allograft

Renal

Kidney

Transplant

Study placed in the following topic categories:

Sirolimus

Cyclosporine

Clotrimazole

Miconazole

Tioconazole

Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Anti-Bacterial Agents

Antifungal Agents

Therapeutic Uses

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00428064