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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


Phase 4
19 Years
74 Years
Not Enrolling
Both
Transplants and Implants

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The Number of Participants With Acute Rejection Episodes

Outcome Description:

Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.

Outcome Time Frame:

6 and 12 months post-transplant

Safety Issue:

No

Principal Investigator

Simin Goral, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania-Renal Electrolyte and Hypertension Division

Authority:

United States: Institutional Review Board

Study ID:

803242

NCT ID:

NCT00596947

Start Date:

October 2005

Completion Date:

March 2009

Related Keywords:

  • Transplants and Implants
  • kidney transplantation
  • tacrolimus
  • Prograf
  • mycophenolate mofetil
  • CellCept
  • corticosteroid withdrawal
  • prednisone withdrawal
  • prednisone maintenance
  • rabbit antithymocyte globulin
  • Thymoglobulin

Name

Location
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104