Conditions: Pharmacokinetics Study in de Novo Kidney Transplantation
Keywords: Pharmacokinetics Study Tacroliums GFR kidney transplant rejection allograft rejection xenograft rejection host vs graft disease renal transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: no

Brief summary:
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.

Detailed description:
In Phase II of this study there was a high patient drop-out rate and an associated long recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition to 81) patients were to be required to achieve calculated sample size. Therefore the protocol was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During this visit patients were informed by the investigator about the end of study and advised about further treatment course.

Arms:
arm 1: Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® arm 2: Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®

Interventions: intervention 1: Prograf intervention 2: Tacrolimus Hexal
Intervention descriptions: intervention 1: Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths. intervention 2: Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,

1 mg and 1.5 mg.

Protocol document: