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Renal FailurePhase 3LCPTacro3002NCT01187953

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

A Phase 3 study testing Prograf (tacrolimus) and LCP-Tacro in people with Renal Failure, run by Veloxis Pharmaceuticals at 86 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Failure
What is being tested?
Prograf (tacrolimus) and LCP-Tacro
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
543 participants
Where
86 sitesin 15 countries
Study dates
Sep 2010to Mar 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • informed consent
  • 18 and 70 years, inclusive
  • receiving primary or secondary renal allograft from a deceased donor or non-human leukocyte antigen (HLA) identical living donor
  • no known contraindications to the administration of IL-2 receptor antagonist induction therapy, MMF, corticosteroids or tacrolimus
  • negative pregnancy test
  • Negative cross match test, and compatible (A, B, AB or O) blood type
  • Able to swallow tablets and capsules

Who cannot join

  • Recipients of any non-renal transplant (solid organ or bone marrow) ever
  • Panel reactive antibody (PRA) >30%
  • Patients with any condition that may affect study drug absorption (e.g. gastrectomy or clinically significant diabetic gastroenteropathy)
  • Body mass index (BMI) 18 kg/m2
  • History of alcohol abuse
  • History of recreational drug abuse
Show all 30Show fewer
  • Screening 12-lead electrocardiogram (ECG) demonstrating clinically relevant abnormalities
  • WOCBP who are either pregnant, lactating, planning to become pregnant
  • Patients with an oral temperature (prior to study drug dosing) of 38.0 ºC (100.4 ºF) or higher
  • Patients with clinically significant active infections
  • Patients with a known hereditary immunodeficiency
  • Patients with malignancies or with a history of malignancies (within the last 5 years)
  • Patients who are receiving or expect to receive sirolimus, everolimus, azathioprine,or cyclophosphamide within 3 months prior to enrollment
  • Patients with evidence of clinically significant disease (e.g., cardiac, gastrointestinal or hepatic disorders)
  • Patients with reversible cardiac ischemia (history of untreated reversible ischemia on stress test)
  • Patients with clinically symptomatic congestive heart failure or documented ejection fraction of less than 45%
  • Patients with significant chronic obstructive pulmonary disease, pulmonary restrictive disease or significant pulmonary hypertension
  • Treatment with an investigational drug, device or regimen within 1 year preceding the first dose of study drug
  • Patients who are unwilling to refrain from consumption of grapefruit or grapefruit containing juices
  • Patients receiving concomitant drugs that may affect concentrations of tacrolimus in whole blood, as listed in Appendix 2
  • Laboratory variables that are abnormal (outside laboratory reference range) and clinically relevant, as judged by the Investigator
  • 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).
  • Patients who experienced graft loss within 1 year of transplant, due to acute rejection or due to BK nephropathy
  • Patients having experienced focal segmental glomerulosclerosis (FSGS)
  • Donor with positive serological test result for HIV-1, HBV or HCV
  • Donor with history of malignant disease (current or historical)
  • Centers for Disease Control and Prevention high-risk donor
  • Patients with mental dysfunction or inability to cooperate with the study
  • Cold ischemia time >30 hours
  • 29. Non-heart-beating donor

Trial locations and contacts

86 sites in 15 countries.

86 sites in 15 countries

United States46 sites

  • Clinical Site 1060

    Albany, New York, 12208

  • Clinical Site 1055

    Atlanta, Georgia, 30309

  • Clinical Site 1020

    Birmingham, Alabama, 35294

  • Clinical Site 1014

    Boston, Massachusetts, 02111

  • Clinical Site 1042

    Buffalo, New York, 14203

  • Clinical Site 1051

    Chapel Hill, North Carolina, 27599

  • Clinical Site 1012

    Charleston, South Carolina, 29425

  • Clinical Site 1053

    Chicago, Illinois, 60612

  • Clinical Site 1005

    Cleveland, Ohio, 44106

  • Clinical Site 1011

    Denver, Colorado, 80220

  • Clinical Site 1018

    Detroit, Michigan, 48236

  • Clinical Site 1032

    Durham, North Carolina, 27710

  • Clinical Site 1040

    East Setauket, New York, 11733

  • Clinical Site 1036

    Gainesville, Florida, 32610

  • Clinical Site 1058

    Greenville, North Carolina, 27834

  • Clinical Site 1048

    Hackensack, New Jersey, 07601

  • Clinical Site 1054

    Harrisburg, Pennsylvania, 17105-8700

  • Clinical Site 1029

    Houston, Texas, 77030

  • Clinical Site 1037

    Livingston, New Jersey, 07039

  • Clinical Site 1031

    Loma Linda, California, 92354

  • Clinical Site 1009

    Los Angeles, California, 90024

  • Clinical Site 1046

    Madison, Wisconsin, 53792

  • Clinical Site 1013

    Miami, Florida, 33136

  • Clinical Site 1008

    Milwaukee, Wisconsin, 53226

  • Clinical Site 1047

    Nashville, Tennessee, 37232

  • Clinical Site 1033

    New Brunswick, New Jersey, 08901

  • Clinical Site 1003

    New Haven, Connecticut, 06520

  • Clinical Site 1026

    New Orleans, Louisiana, 70112

  • Clinical Site 1050

    New York, New York, 10016

  • Clinical Site 1019

    New York, New York, 10029

  • Clinical Site 1025

    New York, New York, 10065

  • Clinical Site 1038

    Orlando, Florida, 32804

  • Clinical Site 1056

    Peoria, Illinois, 61603

  • Clinical Site 1023

    Philadelphia, Pennsylvania, 19102

  • Clinical Site 1052

    Portland, Maine, 04102

  • Clinical Site 1021

    Providence, Rhode Island, 02903

  • Clinical Site 1027

    Richmond, Virginia, 23298

  • Clinical Site 1022

    Sacremento, California, 95817

  • Clinical Site 1061

    San Antonio, Texas, 78215-2035

  • Clinical Site 1039

    San Antonio, Texas, 78229

  • Clinical Site 1045

    San Diego, California, 92103

  • Clinical Site 1049

    San Diego, California, 92123

  • Clinical Site 1044

    San Francisco, California, 94115

  • Clinical Site 1006

    Tampa, Florida, 33606

  • Clinical Site 1035

    The Bronx, New York, 10467

  • Clinical Site 1010

    Valhalla, New York, 10595

Other trials in United States

Australia6 sites

  • Clinical Site 61101

    Camperdown, New South Wales, 2050

  • Clinical Site 61100

    Clayton, Victoria, 3168

  • Clinical Site 61102

    Nedlands, Western Australia, 6009

  • Clinical Site 61104

    Parkville, Victoria, 3050

  • Clinical Site 61106

    Perth, Western Australia, 6000

  • Clinical Site 61105

    Woodville, South Australia, 5011

Other trials in Australia

Brazil6 sites

  • Clinical Site 55178

    Juiz de Fora, 36036-330

  • Clinical Site 55172

    Porto Alegre, Rio Grande Do Sul, 90020-090

  • Clinical Site 55179

    Porto Alegre, Rio Grande Do Sul, 90035-903

  • Clinical Site 55175

    Ribeirão Preto, 14048-900

  • Clinical Site 55173

    Rio de Janeiro, 21041-030

  • Clinical Site 55171

    São Paulo, 04038-002

Other trials in Brazil

France4 sites

  • Clinical Site 33132

    Brest, 29609

  • Clinical Site 33131

    Nice, 06002

  • Clinical Site 33136

    Saint-Etienne, 42000

  • Clinical Site 33134

    Toulouse, 31059

Other trials in France

Mexico4 sites

  • Clinical Site 52184

    Aguascalientes, 20230

  • Clinical Site 52181

    Cuernavaca, MOR, 62448

  • Clinical Site 52183

    Mexico City, 14000

  • Clinical Site 52182

    Mexico City, 14080

Other trials in Mexico

Poland3 sites

  • Clinical Site 48151

    Bydgoszcz, 85-064

  • Clinical Site 48148

    Szczecin, 70-111

  • Clinical Site 48149

    Warsaw, 02-006

Other trials in Poland

Serbia3 sites

  • Clinical Site 381140

    Belgrade, 11000

  • Clinical Site 381141

    Niš, 18000

  • Clinical Site 381142

    Novi Sad, 21000

Other trials in Serbia

Spain3 sites

  • Clinical Site 34155

    Barcelona, Catalonia, 08003

  • Clinical Site 34157

    Barcelona, Catalonia, 08035

  • Clinical Site 34151

    L'Hospitalet de Llobregat, Catalonia, 08907

Other trials in Spain

Argentina2 sites

  • Clinical Site 54163

    Buenos Aires, C1425APQ

  • Clinical Site 54164

    Córdoba, X5004CDT

Other trials in Argentina

Germany2 sites

  • Clinical Site 49137

    Berlin, 10117

  • Clinical Site 49139

    Essen, 45122

Other trials in Germany

New Zealand2 sites

  • Clinical Site 64112

    Auckland, 1142

  • Clinical Site 64121

    Wellington South, 6021

Other trials in New Zealand

Singapore2 sites

  • Clinical Site 65127

    Singapore, 119074

  • Clinical Site 65126

    Singapore, 169608

Other trials in Singapore

Italy1 site

  • Clinical Site 39144

    Roma, 00133

Other trials in Italy

South Korea1 site

  • Clinical Site 92113

    Seoul, 138736

Other trials in South Korea

Sweden1 site

  • Clinical Site 46161

    Malmö

Other trials in Sweden

About this study

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

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.

Read the 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 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.

Conditions
Renal Failure
Being tested
Prograf (tacrolimus), LCP-Tacro
Keywords
Tacrolimus, Acute Rejection, Kidney
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prograf (tacrolimus)Drug

    Also called tacrolimus

    Administered per current product labeling

  • LCP-TacroDrug

    Also called Tacrolimus modifed-release

    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.

Study groups in NCT01187953
Study groupRoleWhat they receive
LCP-TacroExperimentalThe 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.
Receives: Drug: LCP-Tacro
Prograf (tacrolimus)ExperimentalStarting 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.
Receives: Drug: Prograf (tacrolimus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.

    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.

    Measured: 360 days

Secondary outcomes (1)

  1. 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.

    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.

    Measured: 734 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionMar 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187953
Sponsor's protocol ID
LCP-Tacro-3002
Acronym
LCPTacro3002
Status last verified
Apr 2016
First submitted
23 Aug 2010
Last updated
18 May 2016
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prograf (tacrolimus) and LCP-Tacro in people with Renal Failure, run by Veloxis Pharmaceuticals at 86 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Australia, Brazil, France, Mexico and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.

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