A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients - Full Text View

Purpose

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept

Condition	Intervention	Phase
Renal Transplantation	Drug: tacrolimus Drug: CellCept Drug: steroids (methylprednisone or prednisone)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation Steroids

Drug Information available for: Prednisone Mycophenolic acid Mycophenolate sodium Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assessment of death, graft loss, or severe acute rejection [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of patient and graf survival [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
Incidence and severity of acute rejection [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
Need for antilymphocyte treatment [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
Graft function [ Time Frame: 6 month, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]
Framingham Coronary Heart Disease Risk Factors [ Time Frame: 6 months, 12 months, yearly up to 5 years ] [ Designated as safety issue: No ]

Enrollment:	397
Study Start Date:	November 1999
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 early steroid cessation	Drug: tacrolimus Oral Other Names: Prograf FK506 Drug: CellCept IV or Oral Other Names: MMF Mycophenolate mofetil Drug: steroids (methylprednisone or prednisone) IV or Oral Other Names: methylprednisone prednisone
Experimental: 2 long-term maintenance steroids	Drug: tacrolimus Oral Other Names: Prograf FK506 Drug: CellCept IV or Oral Other Names: MMF Mycophenolate mofetil Drug: steroids (methylprednisone or prednisone) IV or Oral Other Names: methylprednisone prednisone

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patient is between post kidney transplant day 3-7 and no requirement for dialysis

Exclusion:

Patient is receiving kidney from HLA identical,living donor
Patient is a multi-organ transplant recipient
Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650468

Show 29 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

central contact

Astellas Pharma US, Inc.

More Information

Publications:

Woodle ES; Fujisawa Corticosteroid Withdrawal Study Group. A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report. Transplant Proc. 2005 Mar;37(2):804-8.

Woodle ES, First MR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008 Oct;248(4):564-77.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gaber AO, Moore LW, Alloway RR, Woodle ES, Pirsch J, Shihab F, Henning A, Fitzsimmons W, Holman J, Reisfield R, First MR; Astellas Corticosteroid Withdrawal Study Group. Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal. Transplantation. 2013 Feb 27;95(4):573-9. doi: 10.1097/TP.0b013e3182777efb.

Delgado JC, Fuller A, Ozawa M, Smith L, Terasaki PI, Shihab FS, Eckels DD. No occurrence of de novo HLA antibodies in patients with early corticosteroid withdrawal in a 5-year prospective randomized study. Transplantation. 2009 Feb 27;87(4):546-8.

Responsible Party:	Sr. Manager Clinical Trail Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier:	NCT00650468 History of Changes
Other Study ID Numbers:	20-99-001
Study First Received:	March 17, 2008
Last Updated:	November 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:

Renal Transplantation
Prograf

Additional relevant MeSH terms:

Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013