Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00518271
• Collaborator: (none)
• Enrollment: 120
• Duration (Months): 26

Study Details

Study Description

Brief Summary

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Rapamune® (Sirolimus); Drug: Tacrolimus; Drug: Corticosteroids	Phase 2

Detailed Description

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II, 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: Apr 1, 2000
• Actual Study Completion Date: Jun 1, 2002

Outcome Measures

Primary Outcome Measures

1. Graft function as measured by calculated creatinine clearance at month 6 post-transplantation. []

Secondary Outcome Measures

1. Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy. []

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 donor

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

Exclusion criteria

• Planned antibody induction

• Multiple organ transplants

• Patients at 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, MD, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00518271
• Other Study ID Numbers: 0468E1-100193
• First Posted: Aug 20, 2007
• Last Update Posted: Aug 20, 2007
• Last Verified: Aug 1, 2007

• Additional relevant MeSH terms: Sirolimus; Tacrolimus

Study Results

No Results Posted as of Aug 20, 2007