Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants - Full Text View

Purpose

Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

Condition	Intervention	Phase
Kidney Transplant	Drug: Cyclosporine	Phase I Phase II

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Cyclosporine Cyclosporin Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Nonrandomized, Open-Label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune

Further study details as provided by Wyeth:

Primary Outcome Measures:

The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.

Secondary Outcome Measures:

To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 12 months post-transplantation.

Estimated Enrollment:	120
Study Start Date:	June 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with end-stage renal disease scheduled to receive a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor.
Subjects must be at least 18 years of age.

Exclusion Criteria:

Subjects with active major infection, including active hepatitis B or C infection, HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257387

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Study ID Numbers:	0468H1-101308
First Received:	November 4, 2005
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00257387
Health Authority:	United States: Institutional Review Board

Keywords provided by Wyeth:

Kidney

Kidney Transplant

Study placed in the following topic categories:

Sirolimus

Cyclosporine

Clotrimazole

Miconazole

Tioconazole

Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antifungal Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antirheumatic Agents

Immunosuppressive Agents

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00257387