Study Evaluating Rapamune® Maintenance Regimen - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00478608

Purpose

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

To evaluate the safety of sirolimus over 6 months after transplantation in Korean renal transplantation recipients.
To evaluate graft function, patient survival and graft survival at 6 months after transplantation.

Condition	Intervention	Phase
Renal Transplant	Drug: Sirolimus (Rapamune®)	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: 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 Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients

Further study details as provided by Wyeth:

Primary Outcome Measures:

Primary efficacy endpoint is the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation. [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1. To evaluate graft function 2. To evaluate subject and graft survival at 3 and 6 months [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	81
Study Start Date:	March 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Sirolimus 1mg/Tablet LD: 6mg/Day MD: 2mg/Day

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 of age.
End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor HLA antigen not shared by the patient.
Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

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 anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478608

Locations

Korea, Republic of

Seoul, Korea, Republic of, 137-701

Deagu, Korea, Republic of, 700-721

Deagu, Korea, Republic of, 700-712

Seoul, Korea, Republic of, 135-710

Suwon, Korea, Republic of, 443-721

Seoul, Korea, Republic of, 138-736

Seoul, Korea, Republic of, 120-752

Pusan, Korea, Republic of, 614-735

Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468E-102362
Study First Received:	May 24, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00478608 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus
Anti-Bacterial Agents
Cyclosporine
Immunologic Factors
Clotrimazole

Miconazole
Antifungal Agents
Tioconazole
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