LCP Tacro 3002


Status: Completed
Keywords: Post renal transplant , immunosuppression , nephrology tranplant , transplant
IRB Number: 00052309
Specialty: Transplant Surgery, Nephrology and Hypertension, Pharmacotherapy
Sub Specialties: Kidney Transplant, Kidney Transplant,

Brief Summary

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

Principal Investigator: Fuad Shihab
Department: Nephrology
Co Investigator: Lonnie Smith
Co Investigator: Adrian Carlson
Co Investigator: Jo Abraham
Co Investigator: Nicole Kenyon
Co Investigator: Crystal Truax
Co Investigator: Faris Ahmed
Co Investigator: Edward Nelson

Contact Information

Name:Amber Lamph
Phone: 801-585-3845

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 (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

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 electrocardiogram (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 38.0 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 a 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