A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients - A2214

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

• Male or female patients = 18 years old.

• Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.

• Recipients of a kidney with a cold ischemia time < 30 hours.

• Recipients of a kidney from a donor 10 – 65 years old.
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

1. Recipients who are unable to receive the first dose of oral study medication within 24 hours after allograft reperfusion.
2. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer.
3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes.
4. Multi-organ transplant recipients.
5. Recipients of an organ from a non-heart beating donor.
6. Complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant (isolated positive B-cell crossmatches are not an exclusion criterion).
7. Patients receiving a second kidney allograft if the first allograft was functional for less than three years (unless lost due to surgical complication).
8. Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.
9. Patients with increased cardiac risk:
o Patients with long QT-syndrome, or QTcF at baseline exceeding 500 msec, or who
are treated with drugs inducing QT prolongation at screening, and cannot discontinue this treatment.
o Patients requiring antiarrhythmic drugs with QT-prolonging properties (class 1a and
class 3).
o Patients with a family history of long QT syndrome or of sudden unexplained death.
o Patients with a history, in the preceding 3 months of significant and persistent
arrhythmias such as ventricular fibrillation or tachycardia, atrial fibrillation or flutter.
o Patients with symptomatic/unstable coronary artery disease (i.e. angina, untreated
cardiac atherosclerotic disease) requiring hospitalization or a revascularization
procedure in the 30 days prior to randomization.
o Patients with chronic heart failure which required hospitalization in the 30 days prior to randomization
10. Patients at high immunological risk, e.g., sensitized patients (most recent anti-HLA class I panel reactive antibodies (PRA) > 20% by a CDC-based assay or > 50% by a flow cytometry, Luminex or enzyme linked immunosorbant assay (ELISA)).
11. Recipients of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
12. Patients with severe systemic infections, current or within the two weeks prior to
randomization.
13. Patients who are anti-HIV-positive, or HBsAg-positive. Anti-HCV positive patients are excluded, except patients who also have a negative polymerase chain reaction (PCR) result. Laboratory results obtained more than six months prior to study entry should be repeated within the first week after randomization. Patients who test positive for any of these viral indicators after randomization will be discontinued from study treatment.
14. Patients with any history of significant coagulopathy or medical condition requiring longterm systemic anticoagulation after transplantation, which would interfere with obtaining biopsies. Low-dose aspirin treatment (up to 200 mg/d is allowed).
15. Evidence of severe liver disease, or abnormal liver profile at screening (a) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times upper limit of normal (ULN) combined with total bilirubin > 2 ULN or (b) AST or ALT > 5 times ULN.
16. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastase

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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