Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

Condition(s) targeted: Transplants and Implants

Intervention: prednisone (Drug); rabbit antithymocyte globulin (Drug); Tacrolimus (Drug); Prednisone (Drug); Mycophenolate mofetil (Drug); Mycophenolate mofetil (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Simin Goral, MD, Principal Investigator, Affiliation: University of Pennsylvania-Renal Electrolyte and Hypertension Division

The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).

Official title: Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Number of Participants With Acute Rejection Episodes

The Number of Participants With Graft Survival

Participant Survival

Secondary outcome:

The Number of Participants With Treatment Failures

Length of Hospital Stay After Transplant

The Number of Participants With Hospital Readmissions

The Length of Stay Associated With Hospital Readmissions

Participant Renal Function as Measured by MDRD Formula

Participant Renal Function as Measured by 24 Hour Urine Collection

The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.

The Number of Participants With Leukopenia

The Number of Participants With Infections

The Number of Participants With Malignancy

The Number of Participants With Hypertension

The Number of Participants With Hyperlipidemia

The Number of Participants With Bone Disease

The Number of Participants With Post Transplant Diabetes Mellitus

The Number of Participants With Weight Gain

Detailed description: Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.

Minimum age: 19 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- First time kidney transplant recipients who receives a kidney from a cadaveric,

living related or living unrelated donor

- Age greater than 18 years and less than 75 years

- Caucasian recipients

- Patients with current low panel reactive antibody (PRA) levels (<10%)

- Patients with signed and dated informed consent

- Women of childbearing potential must have a negative pregnancy test at baseline and

agree to use a medically acceptable method of contraception throughout the treatment period. Exclusion Criteria:

- Other than Caucasian ethnicity

- Patients with HIV+ or

- Patients with HbsAg+ or Hepatitis C positive

- Patients with a history of malignancy in the past 5 years

- Patients with active systemic or localized major infection

- Patients with a history of chronic steroid use for other diseases

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Starting date: October 2005
Last updated: February 18, 2011