Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients

A Multi-centre, Randomized, Open-label, Study to Compare Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients on Maintenance Therapy With Mild to Moderate Renal Insufficiency.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00273871

Enrollment

190

Registered

2006-01-09

Start date

2002-01-31

Completion date

2006-09-30

Last updated

2011-03-08

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

Conditions

Graft Rejection, Kidney Failure, Kidney Transplantation

Keywords

kidney transplant

Brief summary

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

Interventions

DRUGCyclosporin or tacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age over 18 * Treatment with a calcineurin inhibitor * Patients with mild to moderate renal insufficiency

Exclusion criteria

* Patients with acute rejection * Patients who received a transplant more than 10 years ago

Design outcomes

Primary

Measure	Time frame
Difference between treatment groups in renal function at 12 months.	—

Secondary

Measure	Time frame
Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.	—

Outcome results

None listed

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