A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

Astellas Pharma Inc397 enrolled

Overview

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

397

Conditions

Renal Transplantation

Interventions

tacrolimusDRUG

Oral

CellCeptDRUG

IV or Oral

steroids (methylprednisone or prednisone)DRUG

IV or Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion: * Patient is between post kidney transplant day 3-7 and no requirement for dialysis Exclusion: * Patient is receiving kidney from HLA identical,living donor * Patient is a multi-organ transplant recipient * Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control

Locations (29)

Unnamed facility

Little Rock, Arkansas, United States