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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00650468

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Prednisone Tacrolimus anhydrous 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
1: Experimental early steroid cessation	Drug: tacrolimus Oral Drug: CellCept IV or Oral Drug: steroids (methylprednisone or prednisone) IV or Oral
2: Experimental long-term maintenance steroids	Drug: tacrolimus Oral Drug: CellCept IV or Oral Drug: steroids (methylprednisone or prednisone) IV or Oral

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

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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.

Responsible Party:	Astellas Pharma US, Inc ( Sr. Manager Clinical Trail Registry )
Study ID Numbers:	20-99-001
Study First Received:	March 17, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00650468 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:

Renal Transplantation
Prograf

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Mycophenolate mofetil
Tacrolimus
Immunosuppressive Agents
Hormones
Glucocorticoids

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Tacrolimus
Glucocorticoids
Hormones
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Mycophenolate mofetil

ClinicalTrials.gov processed this record on September 11, 2009