Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00519116
• Collaborator: (none)
• Enrollment: 150
• Duration (Months): 10

Study Details

Study Description

Brief Summary

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Rapamune® (Sirolimus); Drug: Tacrolimus; Drug: Perioperative Corticosteroids	Phase 4

Detailed Description

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced-Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
• Study Start Date: Oct 1, 2000
• Study Completion Date: Aug 1, 2001

Outcome Measures

Primary Outcome Measures

1. Calculated creatinine clearance at month 6 post transplantation [6 months]

Secondary Outcome Measures

1. Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus [6 months]

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 a secondary transplant must have maintained a primary graft for at least 6 months

Exclusion criteria:

• Planned antibody induction

• Multiple organ transplants

• History of malignancy within five years of enrollment

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: NCT00519116
• Other Study ID Numbers: 0468E1-100539
• First Posted: Aug 21, 2007
• Last Update Posted: Aug 21, 2007
• Last Verified: Aug 1, 2007

• Additional relevant MeSH terms: Sirolimus; Tacrolimus

Study Results

No Results Posted as of Aug 21, 2007