A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

Astellas Pharma Inc450 enrolled

Overview

A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

450

Conditions

Graft Rejection Kidney Transplantation

Interventions

tacrolimusDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has been on cyclosporine-based immunosuppression regimen since the transplant * Patient has at least one pre-defined risk factor for chronic allograft failure Exclusion Criteria: * Patient is dialysis dependent * Patient is recipient of a solid organ transplant other than the kidney

Locations (18)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

San Francisco, California, United States

Outcomes

Primary Outcomes

Graft Survival

Time frame: 5 years

Secondary Outcomes

Patient survival, Graft Loss

Time frame: 5 years

Data from ClinicalTrials.gov

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