Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

• Status: Completed
• Trial end date: 2017-01-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a real-life setting in different European Countries.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Patient's signed informed consent obtained prior to any study-related procedure;

2. Adult men and women at least 18 years of age with end-stage renal disease who are recipients (or will be recipients) of a kidney transplant from a living or deceased donor;

3. No known contraindications to the administration of tacrolimus, other macrolides and study drugs excipients;

4. Patients must agree to use a highly reliable method of birth control;

5. Donor-recipient negative cross match test, and compatible AB0 blood type;

6. Able to swallow tablets and capsules

Exclusion Criteria:

1. Recipient of any transplanted organ other than kidney;

2. Recipient of a previous renal transplant;

3. Recipient of a kidney from a donor after cardiac death;

4. Recipient of a kidney from an AB0 incompatible or positive cross-match donor;

5. Current (not older than 3 months) anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%. Whenever PRA, either complement-dependent cytotoxicity-PRA or calculated PRA , is not available, patients who are positive on solid-phase screening assay for anti-HLA antibodies must not be enrolled;

6. Recipient of a kidney with a cold ischemia time of ≥ 30 hours;

7. White blood cells count ≤ 2.8x109 cells/L unless ANC >1.0x109/L;

8. Platelet count < 50 x109 cells/L;

9. ALT or AST levels >3 times the normal upper limit during the 30 days prior transplant procedure;

10. Current abuse of drugs or alcohol;

11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;

12. Treatment with any other investigational agent in the 30 days prior to enrolment;

13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);

14. Kidney recipients and/or donors positive for HBV (HBV-DNA or HBS-Ag positive);

15. Recipients positive for HIV;

16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;

17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;

18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;

19. Known hypersensitivity to tacrolimus other macrolides and study drugs excipients;

20. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use reliable methods of contraception