Clinical trial NCT00284921: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: De Novo Kidney Transplant
Keywords: kidney transplant, hepatitis C, enteric-coated mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hepatic function tests (ALT/AST) after 12 months treatment.
Secondary outcomes:
measure: Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
measure: Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
measure: Glomerular filtration rate and by proteinuria after 12 months treatment.
measure: Graft survival after 12 months.
measure: Incidence of AEs and SAEs after 3 and 12 months.
measure: Blood pressure, lipids and glucose profiles after 3 and 12 months.
measure: Percentage of patients free of steroids at 12 months between the two investigational groups.
measure: Viral load (HCV RNA) between both groups at 12 months.
measure: Bone density at 12 months in both groups.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: