An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrhea - 4xMMF

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000033-19-NL

Enrollment

Registered

2007-03-02

Start date

2007-06-05

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Diarrhea in renal transplanted patients which use Cellcept® MedDRA version: 9.1 Level: LLT Classification code 10021176 Term: Iatrogenic diarrhea MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant MedDRA version: 9.1 Level: LLT Classification code 10054980 Term: Immunosuppressant drug therapy

Interventions

Trade Name: CellCept® (mycophenolate mofetil) Pharmaceutical Form: Tablet INN or Proposed INN: MYCOPHENOLATE MOFETIL CAS Number: 115007346 Current Sponsor code: mmf4dd Other descriptive name: 4xMMF Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female > 18 years old Renal transplantation > 6 months with stable renal function (serum creatinine 1 month = 3 times a day loose/ watery stool in at least 75% of the cases) Willing and capable to give written informed consent Able to communicate and cooperate with the investigators Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Usage of morfinomimetics, anti-diarretics, laxans or other drugs that are known to induce diarrhea. Recent use of antibiotics (< 4 weeks before study) Gastro-intestinal infections (Yersinea, Campylobacter, Shigella, Salmonella, Clostridium difficile toxin, CMV) Known gastro-intestinal diseases or recent major gastro-intestinal surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure.;Secondary Objective: Increasing the quality of life and effect on intestinal permeability.;Primary end point(s): - Stool frequency and faeces weight - Incidence of acute graft rejection (according to BANFF 1997 criteria)	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026