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A Study Comparing Corticosteroid Withdrawal to Continuation in Kidney Transplantation With Thymoglobulin Induction, Mycophenolate Mofetil and Tacrolimus Based-immunosuppression
This study has been terminated.
( due to low study enrollment )
First Received: January 8, 2008   Last Updated: July 14, 2009   History of Changes
Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596947
  Purpose

The purpose of the study is to determine if rapid discontinuation of corticosteroids and maintenance immunosuppression with Prograf (Tacrolimus) and CellCept (Mycophenolate mofetil) will give similar safety and efficacy results compared to standard maintenance with Prograf, CellCept and corticosteroids (triple therapy) while using Thymoglobulin (another immunosuppressive medication used to prevent acute rejection at the time of transplantation) in patients.


Condition Intervention Phase
Kidney Transplantation
Drug: Corticosteroid withdrawal
Drug: Continuation of prednisone
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Composite end-point of acute rejection, graft survival and patient survival at 6-months and at 1-year [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of renal function at 6 months and 1 year by MDRD formula, 24 hour urine collection and Glofil [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Evaluation of the incidence of treatment failures: defined as the percentage of patients that do not remain on initial therapy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluation of the incidence of leukopenia, infections and malignancies [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluation of the incidence, severity and treatment of rejection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluation of complications associated with corticosteroid therapy: bone disease, diabetes, hyperlipidemia, weight gain and hypertension [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluation of length of hospital stay, readmissions, and cumulative lengths of stay [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: October 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Experimental
If you are randomized to Group 1, you will start on 3 drugs; Prograf, CellCept and corticosteroids. However, your dose of corticosteroids will rapidly be decreased until completely eliminated by day 6 after transplant
Drug: Corticosteroid withdrawal

If you are randomized to Group 1, you will start on 3 drugs; Prograf, CellCept and corticosteroids.

However,your dose of corticosteroids will rapidly be decreased until complete elimination by day 6 after transplant

Group 2: No Intervention
If you are randomized to Group 2, you will start on 3 drugs; Prograf, CellCept and corticosteroids. You will remain on all three drugs according to your doctors' standard of care and the corticosteroids will not be eliminated.
Drug: Continuation of prednisone
If you are randomized to Group 2, you will start on 3 drugs; Prograf, CellCept and corticosteroids. You will remain on all three drugs according to your doctors' standard of care and the corticosteroids will not be eliminated.

Detailed Description:

Corticosteroids 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.

You will start receiving antirejection medications (thymoglobulin and steroids) while you are in the operating room before the transplant surgical procedure is completed and the rest of the doses will be given while you are on the transplant floor (Thymoglobulin is given as an intravenous infusion for a total of 3-5 doses). Regardless of which treatment group you are randomized to, you will start taking your oral (by mouth) antirejection treatment within 24 hours of the transplant. All patients will be started on three (3) oral antirejection medications:

  1. If you are randomized to Group 1, you will start on 3 drugs; Prograf, CellCept and corticosteroids. However, your dose of corticosteroids will rapidly be decreased until completely eliminated by day 6 after transplant.
  2. If you are randomized to Group 2, you will start on 3 drugs; Prograf, CellCept and corticosteroids. You will remain on all three drugs according to your doctors' standard of care and the corticosteroids will not be eliminated.
  Eligibility

Ages Eligible for Study:   19 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596947

Locations
United States, Pennsylvania
Hospital of the University od Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Simin Goral, MD University of Pennsylvania-Renal Electrolyte and Hypertension Division
  More Information

No publications provided

Responsible Party: Hospital of the University of Pennsylvania ( Simin Goral )
Study ID Numbers: 803242
Study First Received: January 8, 2008
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00596947     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
kidney transplantation
tacrolimus
mycophenolate mofetil
corticosteroid withdrawal
rabbit antithymocyte globulin

Study placed in the following topic categories:
Antilymphocyte Serum
Anti-Bacterial Agents
Prednisone
Immunologic Factors
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Immunosuppressive Agents

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolic Acid
Mycophenolate mofetil
Enzyme Inhibitors
Tacrolimus
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009