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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

Primary Purpose

De Novo Kidney Transplant

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Enteric-coated Mycophenolate sodium (EC-MPS)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for De Novo Kidney Transplant focused on measuring kidney transplant, hepatitis C, enteric-coated mycophenolate sodium

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

Inclusion criteria Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay). 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 Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ. Kidneys from non-heart beating donors. ABO incompatibility against the donor. 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Hepatic function tests (ALT/AST) after 12 months treatment.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 30, 2006
    Last Updated
    November 1, 2011
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00284921
    Brief Title
    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
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    De Novo Kidney Transplant
    Keywords
    kidney transplant, hepatitis C, enteric-coated mycophenolate sodium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Enteric-coated Mycophenolate sodium (EC-MPS)
    Primary Outcome Measure Information:
    Title
    Hepatic function tests (ALT/AST) after 12 months treatment.
    Secondary Outcome Measure Information:
    Title
    Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
    Title
    Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
    Title
    Glomerular filtration rate and by proteinuria after 12 months treatment.
    Title
    Graft survival after 12 months.
    Title
    Incidence of AEs and SAEs after 3 and 12 months.
    Title
    Blood pressure, lipids and glucose profiles after 3 and 12 months.
    Title
    Percentage of patients free of steroids at 12 months between the two investigational groups.
    Title
    Viral load (HCV RNA) between both groups at 12 months.
    Title
    Bone density at 12 months in both groups.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    Inclusion criteria Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay). 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 Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ. Kidneys from non-heart beating donors. ABO incompatibility against the donor. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    Novartis
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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

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