Clinical trial NCT00596947: Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Transplants and Implants
Keywords: kidney transplantation
tacrolimus
Prograf
mycophenolate mofetil
CellCept
corticosteroid withdrawal
prednisone withdrawal
prednisone maintenance
rabbit antithymocyte globulin
Thymoglobulin
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility 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

Primary outcomes:
measure: The Number of Participants With Acute Rejection Episodes
timeFrame: 6 and 12 months post-transplant
measure: The Number of Participants With Graft Survival
timeFrame: 6 and 12 months
measure: Participant Survival
timeFrame: 6 and 12 months
Secondary outcomes:
measure: The Number of Participants With Treatment Failures
timeFrame: 12 months
measure: Length of Hospital Stay After Transplant
timeFrame: 12 months
measure: The Number of Participants With Hospital Readmissions
timeFrame: 12 months
measure: The Length of Stay Associated With Hospital Readmissions
timeFrame: 12 months
measure: Participant Renal Function as Measured by MDRD Formula
timeFrame: 3, 6 and 12 months
measure: Participant Renal Function as Measured by 24 Hour Urine Collection
timeFrame: 3 and 12 months post-transplant
measure: The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.
timeFrame: 12 months
measure: The Number of Participants With Leukopenia
timeFrame: 12 months
measure: The Number of Participants With Infections
timeFrame: 12 months
measure: The Number of Participants With Malignancy
timeFrame: 12 months
measure: The Number of Participants With Hypertension
timeFrame: 12 months
measure: The Number of Participants With Hyperlipidemia
timeFrame: 12 months
measure: The Number of Participants With Bone Disease
timeFrame: baseline (within 1 month post-transplant), 3, 6, 12 and 24 months
measure: The Number of Participants With Post Transplant Diabetes Mellitus
timeFrame: pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months
measure: The Number of Participants With Weight Gain
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania-Renal Electrolyte and Hypertension Division
name: Simin Goral, MD
role: PRINCIPAL_INVESTIGATOR
References: