NCT00420472

Brief Summary

This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (\<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

January 10, 2007

Last Update Submit

November 19, 2007

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.

Secondary Outcomes (1)

  • Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.

Interventions

mycophenolate mofetil [CellCept]DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • first or second kidney transplant;
  • EC-MPS therapy for \>=6 months, with a stable dose for \>=2 months;
  • lower than recommended dose of EC-MPS (\<1440g/day) due to gastrointestinal complaints.

You may not qualify if:

  • patients who have participated in this study before;
  • patients currently participating in another clinical trial, or who participated in one during the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Cologne, 51109, Germany

Location

Unknown Facility

Dresden, 01307, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Münster, 48149, Germany

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

March 1, 2007

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

DE(7)