Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006514

Trial Description

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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

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Trial Acronym

LCPTacro3002

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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 a kidney 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.

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Organizational Data

  •   DRKS00006514
  •   2015/03/13
  •   2010/08/23
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01187953  (ClinicalTrials.gov)
  •   LCP-Tacro-3002  (Veloxis Pharmaceuticals)
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Health Condition or Problem studied

  •   Renal Failure
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: Prograf (tacrolimus)
  •   Drug: LCP-Tacro
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- 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; 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.

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Secondary Outcome

- For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date.; time frame: 734 days; 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 (day 1 to day 734): death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Brazil
  •   France
  •   Germany
  •   Italy
  •   Korea, Republic of
  •   Mexico
  •   New Zealand
  •   Poland
  •   Serbia
  •   Singapore
  •   Spain
  •   Sweden
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2010/09/30
  •   540
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Veloxis Pharmaceuticals
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • VP, Clinical Operations
    • Alan Glicklich 
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    start of 1:1-Block address contact scientific-contact
    •   [---]*
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  • start of 1:1-Block address public-contact
    • VP, Clinical Operations
    • Alan Glicklich 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   12
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.