Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00518375

Purpose

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Corticosteroids Drug: Rapamune® (Sirolimus) Drug: Neoral® (Cyclosporine)	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Cyclosporine Cyclosporin Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Dose Comparison, Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Official Title:	A Comparative, Open-Label Study to Evaluate Graft Function in de Novo Renal Allograft Recipients Treated With Either a 'Reduced Dose' or a 'Standard Dose' of Cyclosporine in Combination With Sirolimus and Corticosteroids

Further study details as provided by Wyeth:

Primary Outcome Measures:

Calculated creatinine clearance to evaluate renal function at 12 months post transplantation [ Time Frame: 12 months ]

Secondary Outcome Measures:

Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation [ Time Frame: 12 months ]

Estimated Enrollment:	250
Study Start Date:	April 2000
Estimated Study Completion Date:	May 2001

Intervention Details:

Left up to local practice but steroids are typically used perioperatively

Detailed Description:

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

Eligibility

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

Criteria

Inclusion Criteria:

Adults more than 18 years of age
End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
Patients with a secondary transplant must have maintained their primary graft for at least 6 months

Exclusion Criteria:

Planned antibody induction therapy
Multiple organ transplants
Patients at a high risk of acute rejection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518375

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0468E1-100154
Study First Received:	July 27, 2007
Last Updated:	August 16, 2007
ClinicalTrials.gov Identifier:	NCT00518375 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Sirolimus
Anti-Bacterial Agents
Cyclosporine
Clotrimazole
Miconazole

Antifungal Agents
Tioconazole
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on March 13, 2009