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

The incidence of efficacy failure at 12 months between two regimens.

Completed

Looking for future studies?

Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Immune System Diseases Kidney Diseases Kidney Failure, Chronic Kidney Transplantation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapamune

Drug

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Primary completion: 2005
Study completion: 2005
First posted: Sep 6, 2002
Registry last updated: Aug 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed