The purpose of this study is to compare the effectiveness and safety of a new drug called LCP-Tacro™ to Prograf for preventing rejection in kidney transplant subjects when used in combination with MMF and corticosteroids, standard of care immunosuppressants beginning in the period immediately following kidney transplant.

Conditions: Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
MedDRA version: 13.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2008-003241-89-SE

Lead Sponsor: ifeCycle Pharma A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 540

Inclusion Criteria

1. Signed informed consent.
2. Between the ages of 18 and 70 years, inclusive.
3. Patients must be receiving primary or secondary renal allograft from a deceased donor or non- human leukocyte antigen (HLA) identical living donor.
4. Patients must have no known contraindications to the administration of IL-2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus.
5. Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine pregnancy test with a sensitivity of a least 25 mIU/mL) within 1 week prior to beginning therapy. WOCBP must be willing to agree to contraceptive practices as detailed in the Contraception Guidelines.
6. Negative cross match test, and compatible (A, B, AB or O) blood type.
7. Able to swallow tablets and capsules.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 530
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 or > 40 kg/m2, calculated using the formula of BMI = mass/(height2).
5. History of alcohol abuse with less than 6 months of sobriety.
6. History of recreational drug abuse with less than 6 months of documented abstinence.
7. Screening 12-lead ECG demonstrating clinically relevant abnormalities (including QT prolongation).
8. WOCBP who are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test.
9. Patients with an oral temperature (prior to study drug dosing) of 38 ºC (100.4 ºF) or higher.
10. Patients with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) including current, latent or prior tuberculosis infection.
11. Patients with known hereditary immunodeficiency.
12. Patients with malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised: cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ.
13. Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine or cyclophosphamide within 3 months prior to enrollment.
14. Any psychiatric or medical condition (cardiac, pulmonary, CNS, GI, endocrine/metabolic, etc) that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
15. Patients currently enrolled in another investigational device or drug study, and who are in the active treatment phase or are less than 30 days since treatment with the investigational agent (s).
16. Laboratory variables that are abnormal (outside laboratory reference range) and clinically relevant, as judged by the Investigator.
17. 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). Negative results for these serological tests must be documented within 12 months prior to randomization into the study.
18. Patients who experienced graft loss within 1 year of transplant, due to acute rejection or due to BK nephropathy.
19. Patients having experienced primary focal segmental glomerulosclerosis (FSGS).
20. Donor with positive serological test result for HIV-1, HBV or HCV.
21. Donor with history of malignant disease (current or historical).
22. Centers for Disease Control and Prevention high-risk donor.
23. Patients with mental dysfunction or inability to cooperate with the
study.
24. Cold ischemia time >30 hours.
25. Non-heart-beating donor.