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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00238992
First received: October 12, 2005
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238992

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00238992     History of Changes
Other Study ID Numbers: CERL080A2405ES01
Study First Received: October 12, 2005
Last Updated: November 1, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

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

ClinicalTrials.gov processed this record on June 18, 2013