Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients

Renal Allograft Recipients Clinical Trial

Official title:

An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470665
• Other study ID #: 0468H1-903
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2007
• Last updated: May 7, 2007
• Start date: August 2002
• Est. completion date: July 2004

Study information

• Verified date: May 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion criteria:

• Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.

• Age >= 13 years, weight >= 40 kg

• Women must have a negative pregnancy test at study entry

Exclusion criteria

• Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)

• Active systemic infection, or localized major infection or known HIV

• Patients with residual kidney function >20 mL/min

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Allograft Recipients

Intervention

Drug:
• Rapamune

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.