Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

University of Pennsylvania

Status and phase: Terminated; Phase 4

Conditions: Transplants and Implants

Treatments: Drug: Prednisone; Drug: Tacrolimus; Drug: prednisone; Drug: Mycophenolate mofetil; Drug: rabbit antithymocyte globulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00596947

803242

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Prednisone Withdrawal

Experimental group

Description:

Participants randomized to the prednisone withdrawal group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was given intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered to participants an inpatient or outpatient for a total of 3 to 5 doses. Participants also began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued indefinitely. The steroids were initially given in the operating room intravenously at time of transplant as Solu-medrol (methylprednisolone)and were then switched to daily oral prednisone doses. The participant's dose of prednisone was rapidly decreased until it was completely eliminated by day 6 post-transplant.

Treatment:

Drug: Mycophenolate mofetil

Drug: Mycophenolate mofetil

Drug: rabbit antithymocyte globulin

Drug: prednisone

Drug: Tacrolimus

Prednisone Maintenance

Active Comparator group

Description:

Participants randomized to the prednisone maintenance group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was initiated intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered an inpatient or outpatient for a total of 3 to 5 doses. Participants began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued on them indefinitely. The steroids were initially given intravenously in the operating room at time of transplant as Solu-medrol (methylprednisolone) and were then switched to daily oral prednisone tablets. Participants remained on all drugs according to their doctor's standard of care, and the prednisone was not be eliminated.

Treatment:

Drug: Mycophenolate mofetil

Drug: Mycophenolate mofetil

Drug: rabbit antithymocyte globulin

Drug: Prednisone

Drug: Tacrolimus