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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00518375
• Collaborator: (none)
• Enrollment: 250
• Duration (Months): 13

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Rapamune® (Sirolimus); Drug: Neoral® (Cyclosporine); Drug: Corticosteroids	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: 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
• Study Start Date: Apr 1, 2000
• Study Completion Date: May 1, 2001

Outcome Measures

Primary Outcome Measures

1. Calculated creatinine clearance to evaluate renal function at 12 months post transplantation [12 months]

Secondary Outcome Measures

1. Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00518375
• Other Study ID Numbers: 0468E1-100154
• First Posted: Aug 20, 2007
• Last Update Posted: Aug 20, 2007
• Last Verified: Aug 1, 2007

• Additional relevant MeSH terms: Cyclosporine; Sirolimus; Cyclosporins

Study Results

No Results Posted as of Aug 20, 2007