Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238940

Enrollment

Registered

2005-10-14

Start date

2003-02-28

Completion date

2005-09-30

Last updated

2011-01-31

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

Conditions

Renal Transplantation

Keywords

Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)

Brief summary

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

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

Inclusion/

Exclusion criteria

\- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.	—

Secondary

Measure	Time frame
Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.	—
Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation	—
Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup	—
Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.	—
Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.	—

Outcome results

None listed

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