Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. informed consent

2. 18 and 70 years, inclusive

3. receiving primary or secondary renal allograft from a deceased donor or non-human leukocyte antigen (HLA) identical living donor

4. no known contraindications to the administration of IL-2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus

5. negative pregnancy test

6. Negative cross match test, and compatible (A, B, AB or O) blood type

7. Able to swallow tablets and capsules

Exclusion Criteria:

1. Recipients of any non-renal transplant (solid organ or bone marrow) ever

2. Panel reactive antibody (PRA) >30%

3. Patients with any condition that may affect study drug absorption (e.g. gastrectomy or clinically significant diabetic gastroenteropathy)

4. Body mass index (BMI) 18 kg/m2

5. History of alcohol abuse

6. History of recreational drug abuse

7. Screening 12-lead electrocardiogram (ECG) demonstrating clinically relevant abnormalities

8. WOCBP who are either pregnant, lactating, planning to become pregnant

9. Patients with an oral temperature (prior to study drug dosing) of 38.0 ºC (100.4 ºF) or higher

10. Patients with clinically significant active infections

11. Patients with a known hereditary immunodeficiency

12. Patients with malignancies or with a history of malignancies (within the last 5 years)

13. Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine,or cyclophosphamide within 3 months prior to enrollment

14. Patients with evidence of clinically significant disease (e.g., cardiac, gastrointestinal or hepatic disorders)

15. Patients with reversible cardiac ischemia (history of untreated reversible ischemia on stress test)

16. Patients with clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%

17. Patients with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension

18. Treatment with an investigational drug, device or regimen within 1 year preceding the first dose of study drug

19. Patients who are unwilling to refrain from consumption of grapefruit or grapefruit containing juices

20. Patients receiving concomitant drugs that may affect concentrations of tacrolimus in whole blood, as listed in Appendix 2

21. Laboratory variables that are abnormal (outside laboratory reference range) and clinically relevant, as judged by the Investigator

22. Patients with positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV)antibody (HCV Ab).

23. Patients who experienced graft loss within 1 year of transplant, due to acute rejection or due to BK nephropathy

24. Patients having experienced focal segmental glomerulosclerosis (FSGS)

25. Donor with positive serological test result for HIV-1, HBV or HCV

26. Donor with history of malignant disease (current or historical)

27. Centers for Disease Control and Prevention high-risk donor

28. Patients with mental dysfunction or inability to cooperate with the study

29. Cold ischemia time >30 hours

29. Non-heart-beating donor