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Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238992
First Posted: October 14, 2005
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.


Condition Intervention Phase
Kidney de Novo Transplant Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • biopsy proven acute rejection incidence at 1 year post-transplantation

Secondary Outcome Measures:
  • Incidence of biopsy proven acute rejection episodes at 6 months
  • Incidence of treated rejection episodes at 6 months and 1 year
  • Incidence of steroid-resistant episodes at 6 months and 1 year
  • Patient and graft survival at 1 year
  • Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)
  • Percentage of patients free from steroids at 6 months and 1 year
  • Treatment safety

Estimated Enrollment: 144
Study Start Date: December 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria

  • Male or female patients undergoing first kidney transplant.
  • Patients aged 18 -70 years.
  • Patients receiving an ABO identical or compatible graft. Exclusion Criteria
  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
  • Positive HBsAg test
  • Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238992


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00238992     History of Changes
Other Study ID Numbers: CERL080A2405ES01
First Submitted: October 12, 2005
First Posted: October 14, 2005
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action