The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
transplantatie geneeskunde
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Stool frequency and faeces weight
- Incidence of acute graft rejection (according to BANFF 1997 criteria)
Secondary outcome
- Quality of life as measured by the SF36 questionnaire
- Renal function as measured by serum creatinine and creatinine clearance
(Cockcroft-Gault formula)
- Intestinal permeability as measured by the intestinal permeability
lactulose-mannitol test
- Comparison of the 2 hours MMF-AUC (0, 30, 60, 90 and 120 min) between a 2 and
4 times daily schedule
- Faeces bacterial profile
- Incidence of adverse events
- Co-medication used during the study will be analyzed
Background summary
Mycophenolate mofetil (MMF or Cellcept®) is an immunosuppressive that is used
for the prevention of acute rejection in renal transplantation. Its major side
effect is diarrhea, which may lead to MMF dose reductions and discontinuations.
Unfortunately this is associated with an increased risk of graft failure.
Therefore we will investigate the effect of dividing the daily oral dose (4
times instead of 2) on diarrhea in renal transplant patients.
Study objective
The main objective is to find out if dividing the daily oral dose prevents
diarrhea without increasing risk of graft failure. Secondary objective is the
quality of life and effect on intestinal permeability.
Study design
An 18 weeks open crossover intervention study.
Patients will be screened (2 weeks). In the first study period (week 0-8) the
daily oral dose is divided into 4 doses. After 8 weeks patients switch and
receive MMF twice a day for another 8 weeks.
Intervention
The daily oral dose will be divided into 4 doses a day instead of the ususal 2
doses a day
Study burden and risks
Extra procedures:
During the study period (18 weeks) patients visit the hospital 6 times. Serum
creatinine and MPA-AUC will be determined several times. Faeces and urine will
be collected at the end of each period for investigation on bacterial profile
and intestinal permeability respectively. Furthermore, patients have to fill
out quality of life questionnaires and a diary for body weight and stool
frequency.
Risks:
With every change in the immunosuppressive protocol there is a chance of an
acute organ rejection. The chance of this, however, is considered small, since
the total daily dose is unchanged. Moreover, such rejections are nearly always
treatable with the standard therapies available (methylsolumedrol and ATG)
Benefits:
The severity of diarrhea may decrease without an increase in graft rejection,
resulting in a measurable improved quality of life.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Male or female > 18 years old
Renal transplantation > 6 months with stable renal function (serum creatinine < 250 mumol/L)
Use of MMF (Cellcept®) 2 times daily
History of diarrhea (> 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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-000033-19-NL |
| CCMO | NL15396.041.07 |