liver or kidney transplant - stable
Conditions
Interventions
Trade Name: Myfortic 180 mg, comprimé pelliculé gastro-résistant
Product Name: enteric coated MPA
Product Code: ERL080
Pharmaceutical Form: Film-coated tablet
Trade Name: Myfortic 360 mg, comprimé pe
Sponsors
Novartis Pharma N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients aged 18 years and older. 2) Stable kidney or liver transplant recipients. 3) Patients who are currently under MMF treatment and who are currently suffering from upper or lower gastrointestinal adverse events. 4) Patients in a stable condition in terms of graft function (e.g. no change of immune suppressive regimen due to graft malfunction), and no known clinically significant physical and/or laboratory changes prior to enrollment. 5) Females of childbearing potential must have a negative serum pregnancy test prior to inclusion in the trial. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility. 6) Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained. 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: 1) Evidence of graft rejection or treatment of acute rejection prior to screening. 2) Patients with any known hypersensitivity to ERL080A or MMF or other components of the formulation (e.g., lactose). 3) Pre-existing conditions that may cause gastrointestinal complaints such as extensive gastrointestinal surgery in the past, severe cholestatic liver dysfunction, amyloidose, diabetes mellitus, pre-terminal renal insufficiency. 4) Drug induced gastrointestinal complaints with the following drugs: antibiotics (e.g. erythromycin derivatives, cephalosporin,…), NSAID’s, antacids (e.g. H2-antihistaminics, proton pump inhibitors, …), loperamidehydrochloride (Imodium®), Movicol®, colchicines, allopurinol (Zyloric®). 5) Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <9.0 g/dL prior to enrollment. 6) Patients who have received an investigational drug within two weeks prior to screening (i.e., before Day -14 of run-in period). 7) Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. 8) Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. 9) Patients with clinically significant infection requiring continued therapy. 10) Known positive HIV. 11) Evidence of drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to myfortic® in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy. In contrast to previous studies with myfortic®, the study population in the present study will be selected after exclusion of gastrointestinal adverse events from infectious etiology. The assumption is that gastrointestinal adverse events are more likely related to immunosuppressive therapy when infections have been ruled out.;Secondary Objective: none;Primary end point(s): - To compare the baseline VAS score of the upper/lower GI complaints before conversion versus after conversion at month 3. - To compare the number of watery bowel movements before conversion versus after conversion at month 3. | — |
Countries
Belgium
Outcome results
None listed