A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.

Novartis0 sites20 target enrollmentJanuary 2004

ConditionsKidney Transplantation

DrugsEnteric-Coated Mycophenolate sodium (EC-MPS)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Kidney Transplantation
Sponsor: Novartis
Enrollment: 20
Primary Endpoint: Graft function 6 months post transplantation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

March 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

Exclusion Criteria

•Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.
•Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.
•Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).
•Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose).
•Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.
•Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Graft function 6 months post transplantation

Secondary Outcomes

Incidence of biopsy proven acute rejection, graft loss or death within 6 and 12 months post transplantation
Incidence of biopsy proven acute rejection within 6 and 12 months post transplantation
Time to first biopsy-proven acute rejection
Graft survival and patient survival at 6 and 12 months
Severity of biopsy-proven acute rejection