Renal transplant patients MedDRA version: 9.1 Level: LLT Classification code 10044439 Term: Transplant rejection
Conditions
Interventions
Trade Name: Advagraf
Product Name: advagraf
Pharmaceutical Form: Capsule*
INN or Proposed INN: tacrolimus
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Trade Name: Prograft
Product Name
Sponsors
KULeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients transplanted min 6m and max 6years at inclusion time prograft based stable immunosuppressive regimen for at least 3 months patients able to understand purpose and manipulation of Pro Mate electronic monitoring device first or second renal transplantation 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: patient with known clinical need at inclusion of withdrawing prograft from regimen within a period of 9 months after inclusion patients not able to understand manipulation of ProMate electronic monitoring device patients refusing signature of informed consent interruption of prograft /advagraf regimen for more then 10 consecutive days medical reasons rendering the patient not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: comparison of the post-baseline taking adherence (ie.proportion of days during which the electronic monitoring device showed the patient has taken the medication from visit 2 to visit 4) to the prescribed therapy in the advagraf arm compared to the post-baseline taking adherence of the prograft arm;Secondary Objective: Comparison of post-baseline timing adherence in the advagraf arm to the post-baseline timing adherence in the prograft arm comparison of baseline taking adherence with post-baseline taking adherence in the advagraf arm comparison of baseline taking adherence with post-baseline taking adherence in de prograft arm variability of dosing intervals in prograft and advagraf number of drug holidays in prograft and advagraf in post baseline period patient reported adherence in prograft and advagraf according to BAASIS questionnaire correlation between adherence by electronic monitoring device and BAASIS score Patient appreciation of BID vs QD regimen in the conversion cohort Intra-patient variability in tacrolimus serum concentration in Prograft and advagraf acute rejection rate in prograft and advagraf treated patients mean number of dose ;Primary end point(s): comparison of the post-baseline taking adherence to the prescribed therapy in the advagraf arm compared to the post-baseline taking adherence of the prograft arm | — |
Countries
Belgium
Outcome results
None listed