Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239018

Enrollment

144

Registered

2005-10-14

Start date

2003-04-30

Completion date

2005-07-31

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

De Novo Kidney Transplantation

Keywords

Enteric-Coated Mycophenolate Sodium (EC-MPS), de novo, kidney transplantation, long-term safety.

Brief summary

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of 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

Inclusion /

Exclusion criteria

\- All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium. Other protocol-defined inclusion /

Design outcomes

Primary

Measure	Time frame
To assess glomerular filtration rate at month 3 post transplantation	—

Secondary

Measure	Time frame
Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.	—
Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.	—
Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months	—
Incidence of graft and patient survival within 6 and 12 months	—
Safety and tolerability based on adverse event (AE) reporting.	—

Outcome results

None listed

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