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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

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. Identifier: NCT00284921
Recruitment Status : Terminated
First Posted : February 1, 2006
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
De Novo Kidney Transplant Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2004
Actual Primary Completion Date : August 2006

Primary Outcome Measures :
  1. Hepatic function tests (ALT/AST) after 12 months treatment.

Secondary Outcome Measures :
  1. Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
  2. Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
  3. Glomerular filtration rate and by proteinuria after 12 months treatment.
  4. Graft survival after 12 months.
  5. Incidence of AEs and SAEs after 3 and 12 months.
  6. Blood pressure, lipids and glucose profiles after 3 and 12 months.
  7. Percentage of patients free of steroids at 12 months between the two investigational groups.
  8. Viral load (HCV RNA) between both groups at 12 months.
  9. Bone density at 12 months in both groups.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

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 identifier (NCT number): NCT00284921

Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Novartis
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00284921    
Other Study ID Numbers: CERL080AES02
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
kidney transplant, hepatitis C, enteric-coated mycophenolate sodium
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action