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Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients

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ClinicalTrials.gov Identifier: NCT00240955
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by:
Novartis

Brief Summary:
The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Two Immunosuppressive Regimens Mycophenolate Sodium (EC-MPS) With Short-term Steroid Use or Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients
Study Start Date : March 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006





Primary Outcome Measures :
  1. Safety and tolerability of enteric-coated mycophenolate sodium based on adverse event (AE) reporting.


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

Inclusion Criteria/ Exclusion Criteria

  • All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined 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): NCT00240955


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00240955     History of Changes
Other Study ID Numbers: CERL080A2404E1
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Renal/Kidney, Transplantation, steroids, EC-MPS

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