Controlled study on the Relative Pharmacokinetics of Advagraf versus Prograft in Kidney transplant patients with severe Diarrhoea - CORPAD

Conditions: Renal transplant patients suffering from diarrhea
MedDRA version: 12.0Level: LLTClassification code 10038533Term: Renal transplant

Registration Number: EUCTR2009-014670-17-BE

Lead Sponsor: H.-Hartziekenhuis Roeselare-Menen vzw

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

There are no exclusion criteria defined in the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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).<br>

Secondary Outcome Measures