Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:

An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044720
• Other study ID #: 0468H1-101164
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2002
• Last updated: August 17, 2009
• Est. completion date: July 2005

Study information

• Verified date: August 2009
• 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 incidence of efficacy failure at 12 months between two regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

• Age: 13 years or older, 40 kgs or more

• End-stage renal disease

• African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

Exclusion Criteria

• Evidence of active infection

• Evidence abnormal chest x-ray

• Patients with HIV.

Study Design

Allocation: Randomized, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Graft vs Host Disease
• Kidney Failure, Chronic
• Kidney Transplantation
• Renal Insufficiency

Intervention

Drug:
• Rapamune

Locations

Country	Name	City	State
n/a

Sponsors (1)

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