Renal transplant patients suffering from diarrhea MedDRA version: 12.0 Level: LLT Classification code 10038533 Term: Renal transplant
Conditions
Interventions
Trade Name: Prograf(t) Capsules
Product Name: Tacrolimus capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concent
Sponsors
H.-Hartziekenhuis Roeselare-Menen vzw
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient age >= 18 years Patient on a tacrolimus ± MMF regimen For cases, severe diarrhoea >= 7 days and >= 3stools/day For cases, an infective diarrhoea period has been excluded For controls, patient ready to be converted to Advagraf Patients willing to have a 9-point, 12 hour AUC profile taken Patient has understood the study and signed the informed consent 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: There are no exclusion criteria defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the pharmacokinetics and dose-corrected bioavailability of Advagraf relative to Prograft in patients suffering from severe diarrhoea;Secondary Objective: The secondary objectives are to compare the pharmacokinetics and dose-corrected bioavailability of Advagraf relative to Prograft in diarrhoea patients compared to non-diarrhoea patients;Primary end point(s): For all patients and controls a Co value of tacrolimus (= Co AUC 0-12) and an MPA Co value will be measured. Additionally, a 9-point tacrolimus AUC 0-12 will be performed as well, using samples taken at 0 min, 30 min, 60 min (1h), 90 minutes (1,5h), 120 min (2h), 240 min (4h), 360 min (6h), 480 min (8h) and 720 min (12h). | — |
Countries
Belgium
Outcome results
None listed