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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Clinical Site 1020
Birmingham, Alabama, United States, 35294
United States, California
Clinical Site 1031
Loma Linda, California, United States, 92354
Clinical Site 1009
Los Angeles, California, United States, 90024
Clinical Site 1022
Sacremento, California, United States, 95817
Clinical Site 1045
San Diego, California, United States, 92103
Clinical Site 1049
San Diego, California, United States, 92123
Clinical Site 1044
San Francisco, California, United States, 94115
United States, Colorado
Clinical Site 1011
Denver, Colorado, United States, 80220
United States, Connecticut
Clinical Site 1003
New Haven, Connecticut, United States, 06520
United States, Florida
Clinical Site 1036
Gainesville, Florida, United States, 32610
Clinical Site 1013
Miami, Florida, United States, 33136
Clinical Site 1038
Orlando, Florida, United States, 32804
Clinical Site 1006
Tampa, Florida, United States, 33606
United States, Georgia
Clinical Site 1055
Atlanta, Georgia, United States, 30309
United States, Illinois
Clinical Site 1053
Chicago, Illinois, United States, 60612
Clinical Site 1056
Peoria, Illinois, United States, 61603
United States, Louisiana
Clinical Site 1026
New Orleans, Louisiana, United States, 70112
United States, Maine
Clinical Site 1052
Portland, Maine, United States, 04102
United States, Massachusetts
Clinical Site 1014
Boston, Massachusetts, United States, 02111
United States, Michigan
Clinical Site 1018
Detroit, Michigan, United States, 48236
United States, New Jersey
Clinical Site 1048
Hackensack, New Jersey, United States, 07601
Clinical Site 1037
Livingston, New Jersey, United States, 07039
Clinical Site 1033
New Brunswick, New Jersey, United States, 08901
United States, New York
Clinical Site 1060
Albany, New York, United States, 12208
Clinical Site 1035
Bronx, New York, United States, 10467
Clinical Site 1042
Buffalo, New York, United States, 14203
Clinical Site 1040
East Setauket, New York, United States, 11733
Clinical Site 1025
New York, New York, United States, 10065
Clinical Site 1050
New York, New York, United States, 10016
Clinical Site 1019
New York, New York, United States, 10029
Clinical Site 1010
Valhalla, New York, United States, 10595
United States, North Carolina
Clinical Site 1051
Chapel Hill, North Carolina, United States, 27599
Clinical Site 1032
Durham, North Carolina, United States, 27710
Clinical Site 1058
Greenville, North Carolina, United States, 27834
United States, Ohio
Clinical Site 1005
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Clinical Site 1054
Harrisburg, Pennsylvania, United States, 17105-8700
Clinical Site 1023
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
Clinical Site 1021
Providence, Rhode Island, United States, 02903
United States, South Carolina
Clinical Site 1012
Charleston, South Carolina, United States, 29425
United States, Tennessee
Clinical Site 1047
Nashville, Tennessee, United States, 37232
United States, Texas
Clinical Site 1029
Houston, Texas, United States, 77030
Clinical Site 1039
San Antonio, Texas, United States, 78229
Clinical Site 1061
San Antonio, Texas, United States, 78215-2035
United States, Virginia
Clinical Site 1027
Richmond, Virginia, United States, 23298
United States, Wisconsin
Clinical Site 1046
Madison, Wisconsin, United States, 53792
Clinical Site 1008
Milwaukee, Wisconsin, United States, 53226
Argentina
Clinical Site 54163
Buenos Aires, Argentina, C1425APQ
Clinical Site 54164
Cordoba, Argentina, X5004CDT
Australia, New South Wales
Clinical Site 61101
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Clinical Site 61105
Woodville, South Australia, Australia, 5011
Australia, Victoria
Clinical Site 61100
Clayton, Victoria, Australia, 3168
Clinical Site 61104
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Clinical Site 61102
Nedlands, Western Australia, Australia, 6009
Clinical Site 61106
Perth, Western Australia, Australia, 6000
Brazil
Clinical Site 55178
Juiz de Fora, Brazil, 36036-330
Clinical Site 55172
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Clinical Site 55179
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Clinical Site 55175
Ribeirao Preto, Brazil, 14048-900
Clinical Site 55173
Rio de Janeiro, Brazil, 21041-030
Clinical Site 55171
Sao Paulo, Brazil, 04038-002
France
Clinical Site 33132
Brest, France, 29609
Clinical Site 33131
Nice, France, 06002
Clinical Site 33136
Saint Etienne, France, 42000
Clinical Site 33134
Toulouse, France, 31059
Germany
Clinical Site 49137
Berlin, Germany, 10117
Clinical Site 49139
Essen, Germany, 45122
Italy
Clinical Site 39144
Roma, Italy, 00133
Korea, Republic of
Clinical Site 92113
Seoul, Korea, Republic of, 138736
Mexico
Clinical Site 52184
Aguascalientes, Mexico, 20230
Clinical Site 52181
Cuernavaca, MOR, Mexico, 62448
Clinical Site 52182
Mexico City, Mexico, 14080
Clinical Site 52183
Mexico City, Mexico, 14000
New Zealand
Clinical Site 64112
Auckland, New Zealand, 1142
Clinical Site 64121
Wellington South, New Zealand, 6021
Poland
Clinical Site 48151
Bydgoszcz, Poland, 85-064
Clinical Site 48148
Szczecin, Poland, 70-111
Clinical Site 48149
Warszawa, Poland, 02-006
Serbia
Clinical Site 381140
Beograd, Serbia, 11000
Clinical Site 381141
Nis, Serbia, 18000
Clinical Site 381142
Novi Sad, Serbia, 21000
Singapore
Clinical Site 65126
Singapore, Singapore, 169608
Clinical Site 65127
Singapore, Singapore, 119074
Spain
Clinical Site 34157
Barcelona, Cataluña, Spain, 08035
Clinical Site 34155
Barcelona, Cataluña, Spain, 08003
Clinical Site 34151
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Sweden
Clinical Site 46161
Malmo, Sweden
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
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014