Double-Blind,Double-Dummy,Effic/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx (LCPTacro3002)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01187953
First received: August 23, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Renal Failure
Drug: Prograf (tacrolimus)
Drug: LCP-Tacro
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro™ Tablets, QD, Compared to Prograf® Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Veloxis Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint for the study is the proportion of treatment failures within 12 months after randomization to study drug. [ Time Frame: 360 days ] [ Designated as safety issue: No ]
    Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.


Enrollment: 540
Study Start Date: September 2010
Estimated Study Completion Date: April 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCP-Tacro
The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
Drug: LCP-Tacro
Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
Other Name: Tacrolimus modifed-release
Experimental: Prograf (tacrolimus)
Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.
Drug: Prograf (tacrolimus)
Administered per current product labeling
Other Name: tacrolimus

Detailed Description:

This is a two-armed parallel group, prospective, randomized, double-blind, double-dummy,multicenter Phase 3 clinical study to establish the efficacy and safety of LCP-Tacro Tablets (tacrolimus, LifeCycle Pharma A/S, Hørsholm, Denmark) once daily for the prevention of allograft rejection in de novo adult male and female recipients of a primary or secondary kidney transplant evaluated by a combined efficacy endpoint comprised of acute rejection, graft loss and patient loss. The trial is designed to determine if the test drug, LCP-Tacro, is not inferior to an unacceptable extent to the reference compound, Prograf. Recipients of akidney transplant who sign an informed consent form and fulfill all other inclusion and exclusion criteria will be randomly assigned to once-daily therapy with LCP-Tacro Tablets or to twice-daily therapy with Prograf Capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL), each concomitantly administered with mycophenolate mofetil (MMF) and corticosteroids. All patients will also receive interleukin-2 (IL-2) receptor antagonist (e.g.,Simulect®, basiliximab; Novartis Pharmaceuticals, East Hanover, NJ). Following screening,transplantation, and randomization, study visits will be conducted over a 12-month treatment period; with additional visits during a 12 month extension period on treatment and a follow-up safety assessment by visit or telephone interview 30 days after withdrawal from study drug.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187953

  Show 86 Study Locations
Sponsors and Collaborators
Veloxis Pharmaceuticals
Investigators
Study Director: Alan Glicklich VP, Clinical Operations
  More Information

No publications provided

Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01187953     History of Changes
Other Study ID Numbers: LCP-Tacro-3002
Study First Received: August 23, 2010
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Veloxis Pharmaceuticals:
Tacrolimus
Acute Rejection
Kidney

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014