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Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238953
First Posted: October 14, 2005
Last Update Posted: February 23, 2017
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:
Novartis
  Purpose
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

Condition Intervention Phase
Renal Transplantation Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 6 Month evaluation
  • patient and graft survival
  • acute rejection (suspected or biopsy confirmed)
  • graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
  • infections, adverse events, serious adverse events.

Secondary Outcome Measures:
  • Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EC MPS Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

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

Inclusion criteria:

  • Male and females aged 18 to 75
  • Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria:

  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
  • Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
  • Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.

Other 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): NCT00238953


Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00238953     History of Changes
Other Study ID Numbers: CERL080APL01
First Submitted: October 12, 2005
First Posted: October 14, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Kidney transplantation
enteric-coated mycophenolate sodium

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


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