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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01187953




Registration number
NCT01187953
Ethics application status
Date submitted
23/08/2010
Date registered
24/08/2010
Date last updated
18/05/2016

Titles & IDs
Public title
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
Scientific 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
Secondary ID [1] 0 0
LCP-Tacro-3002
Universal Trial Number (UTN)
Trial acronym
LCPTacro3002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Prograf (tacrolimus)
Treatment: Drugs - LCP-Tacro

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.

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.


Treatment: Drugs: Prograf (tacrolimus)
Administered per current product labeling

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.
Timepoint [1] 0 0
360 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
734 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
543
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Clinical Site 61101 - Camperdown
Recruitment hospital [2] 0 0
Clinical Site 61105 - Woodville
Recruitment hospital [3] 0 0
Clinical Site 61100 - Clayton
Recruitment hospital [4] 0 0
Clinical Site 61104 - Parkville
Recruitment hospital [5] 0 0
Clinical Site 61102 - Nedlands
Recruitment hospital [6] 0 0
Clinical Site 61106 - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Illinois
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Louisiana
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Maine
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Brazil
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Juiz de Fora
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Brazil
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Porto Alegre, Rio Grande do Sul
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Brazil
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Ribeirao Preto
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Rio de Janeiro
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Sao Paulo
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Brest
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Nice
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France
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Saint Etienne
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France
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Toulouse
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Germany
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Berlin
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Germany
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Essen
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Italy
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Roma
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Korea, Republic of
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Seoul
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Aguascalientes
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Mexico
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Cuernavaca, MOR
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Mexico
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Mexico City
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New Zealand
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Auckland
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New Zealand
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Wellington South
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Poland
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Bydgoszcz
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Szczecin
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Warszawa
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Serbia
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Beograd
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Serbia
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Nis
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Serbia
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Novi Sad
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Singapore
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Singapore
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Spain
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Cataluña
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Sweden
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Malmo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Veloxis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01187953
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan Glicklich
Address 0 0
VP, Clinical Operations
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01187953