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.

Phase 4

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00154245
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Graft function 6 months post transplantation

Secondary Outcome Measures

Name	Time	Method
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