A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

Phase 1

Conditions: Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
MedDRA version: 12.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejection

Registration Number: EUCTR2008-003241-89-FR

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) should 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 (Section 8.2.4).
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:
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 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 QTc prolongation, reversible ischemia and clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%).
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. Patients with evidence of clinically significant disease (e.g., cardiac, gastrointestinal or hepatic disorders) that places the patient at increased risk for participating in the study and/or will confound the result of the study.
15. Patients with reversible 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 for the duration of the study period.
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). Negative results for these serological tests must be documented within 12 months prior to randomization.
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 me

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

Related Trials

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.

Veloxis Pharmaceuticals A/S

Updated 10/27/2014