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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044720

Enrollment

484

Registered

2002-09-06

Start date

Unknown

Completion date

2005-07-31

Last updated

2009-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation

Keywords

Kidney Transplant

Brief summary

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

Interventions

DRUGRapamune

Study design

Allocation

RANDOMIZED

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026