MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00284921
First received: January 30, 2006
Last updated: November 1, 2011
Last verified: November 2011

January 30, 2006
November 1, 2011
April 2004
August 2006   (final data collection date for primary outcome measure)
Hepatic function tests (ALT/AST) after 12 months treatment.
Not Provided
Complete list of historical versions of study NCT00284921 on ClinicalTrials.gov Archive Site
  • Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
  • Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
  • Glomerular filtration rate and by proteinuria after 12 months treatment.
  • Graft survival after 12 months.
  • Incidence of AEs and SAEs after 3 and 12 months.
  • Blood pressure, lipids and glucose profiles after 3 and 12 months.
  • Percentage of patients free of steroids at 12 months between the two investigational groups.
  • Viral load (HCV RNA) between both groups at 12 months.
  • Bone density at 12 months in both groups.
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MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive

To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
De Novo Kidney Transplant
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
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August 2006   (final data collection date for primary outcome measure)

Inclusion criteria

  1. Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
  2. Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.

Exclusion criteria

  1. Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
  2. Kidneys from non-heart beating donors.
  3. ABO incompatibility against the donor.
  4. Patients with panel reactive antibodies of >50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.
Both
18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00284921
CERL080AES02
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP