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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154245

Enrollment

Registered

2005-09-12

Start date

2004-01-31

Completion date

2006-03-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Enteric-coated mycophenolate sodium, transplantation, de novo, cyclosporine

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.

Interventions

DRUGEnteric-Coated Mycophenolate sodium (EC-MPS)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
Graft function 6 months post transplantation	—

Secondary

Measure	Time frame
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	—
Severity of biopsy-proven acute rejection	—
Graft survival and patient survival at 6 and 12 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026