Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00507793
• Collaborator: (none)
• Enrollment: 385
• Duration (Months): 26

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Sirolimus; Drug: Cyclosporine	Phase 4

Detailed Description

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 385 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
• Study Start Date: Apr 1, 2000
• Actual Study Completion Date: Jun 1, 2002

Outcome Measures

Primary Outcome Measures

1. A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine. []

Secondary Outcome Measures

1. Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance. []

Eligibility Criteria

Criteria

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

Inclusion criteria

• At least 18 years of age

• End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor

• Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

• Antibody induction within one week of current transplantation

• Multiorgan transplants

• Patients at high-risk of 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: NCT00507793
• Other Study ID Numbers: 0468E1-4351
• First Posted: Jul 27, 2007
• Last Update Posted: Jul 27, 2007
• Last Verified: Jul 1, 2007

• Additional relevant MeSH terms: Cyclosporine; Sirolimus; Cyclosporins

Study Results

No Results Posted as of Jul 27, 2007