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

Astellas

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: steroids (methylprednisone or prednisone); Drug: tacrolimus; Drug: CellCept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650468

20-99-001

Details and patient eligibility

About

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

Enrollment: 397 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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397 participants in 2 patient groups

1

Experimental group

Description:

early steroid cessation

Treatment:

Drug: CellCept

Drug: tacrolimus

Drug: steroids (methylprednisone or prednisone)

2

Experimental group

Description:

long-term maintenance steroids

Treatment:

Drug: CellCept

Drug: tacrolimus

Drug: steroids (methylprednisone or prednisone)