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Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

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ClinicalTrials.gov Identifier: NCT00239018
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : January 31, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS

Condition or disease Intervention/treatment Phase
De Novo Kidney Transplantation Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
Study Start Date : April 2003
Primary Completion Date : July 2005
Study Completion Date : July 2005





Primary Outcome Measures :
  1. To assess glomerular filtration rate at month 3 post transplantation

Secondary Outcome Measures :
  1. Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.
  2. Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.
  3. Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months
  4. Incidence of graft and patient survival within 6 and 12 months
  5. Safety and tolerability based on adverse event (AE) reporting.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion / Exclusion Criteria

- All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply


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): NCT00239018


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00239018     History of Changes
Other Study ID Numbers: CERL080A2405FR01E1
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Enteric-Coated Mycophenolate Sodium (EC-MPS), de novo, kidney transplantation, long-term safety.

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