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

De Novo Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00284921
• Other study ID #: CERL080AES02
• Status: Terminated
• Phase: Phase 3
• First received: January 30, 2006
• Last updated: November 1, 2011
• Start date: April 2004

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. primary completion date: August 2006
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• De Novo Kidney Transplant
• Hepatitis C

Intervention

Drug:
• Enteric-coated Mycophenolate sodium (EC-MPS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic function tests (ALT/AST) after 12 months treatment.
Secondary	Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
Secondary	Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
Secondary	Glomerular filtration rate and by proteinuria after 12 months treatment.
Secondary	Graft survival after 12 months.
Secondary	Incidence of AEs and SAEs after 3 and 12 months.
Secondary	Blood pressure, lipids and glucose profiles after 3 and 12 months.
Secondary	Percentage of patients free of steroids at 12 months between the two investigational groups.
Secondary	Viral load (HCV RNA) between both groups at 12 months.
Secondary	Bone density at 12 months in both groups.