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

NCT01187953 | Completed Phase 3 Results DMC

• 1 other identifier: LCP-Tacro-3002
• Study Type: interventional
• Target: 543
• Locations: 14 countries
• Sites: 83

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.

Conditions

Renal Failure

Keywords

Tacrolimus; Acute Rejection; Kidney

Outcome Measures

Primary Outcomes (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.

  360 days

Secondary Outcomes (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.

  734 days

Study Arms (2)

LCP-Tacro

EXPERIMENTAL

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

Prograf (tacrolimus)

EXPERIMENTAL

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)

Interventions

Prograf (tacrolimus) DRUG

Administered per current product labeling

Also known as: tacrolimus

Prograf (tacrolimus)

LCP-Tacro DRUG

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.

Also known as: Tacrolimus modifed-release

LCP-Tacro

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

Study Sites (86)

Clinical Site 1020

Birmingham, Alabama, 35294, United States

Location

Clinical Site 1031

Loma Linda, California, 92354, United States

Location

Clinical Site 1009

Los Angeles, California, 90024, United States

Location

Clinical Site 1022

Sacremento, California, 95817, United States

Location

Clinical Site 1045

San Diego, California, 92103, United States

Location

Clinical Site 1049

San Diego, California, 92123, United States

Location

Clinical Site 1044

San Francisco, California, 94115, United States

Location

Clinical Site 1011

Denver, Colorado, 80220, United States

Location

Clinical Site 1003

New Haven, Connecticut, 06520, United States

Location

Clinical Site 1036

Gainesville, Florida, 32610, United States

Location

Clinical Site 1013

Miami, Florida, 33136, United States

Location

Clinical Site 1038

Orlando, Florida, 32804, United States

Location

Clinical Site 1006

Tampa, Florida, 33606, United States

Location

Clinical Site 1055

Atlanta, Georgia, 30309, United States

Location

Clinical Site 1053

Chicago, Illinois, 60612, United States

Location

Clinical Site 1056

Peoria, Illinois, 61603, United States

Location

Clinical Site 1026

New Orleans, Louisiana, 70112, United States

Location

Clinical Site 1052

Portland, Maine, 04102, United States

Location

Clinical Site 1014

Boston, Massachusetts, 02111, United States

Location

Clinical Site 1018

Detroit, Michigan, 48236, United States

Location

Clinical Site 1048

Hackensack, New Jersey, 07601, United States

Location

Clinical Site 1037

Livingston, New Jersey, 07039, United States

Location

Clinical Site 1033

New Brunswick, New Jersey, 08901, United States

Location

Clinical Site 1060

Albany, New York, 12208, United States

Location

Clinical Site 1042

Buffalo, New York, 14203, United States

Location

Clinical Site 1040

East Setauket, New York, 11733, United States

Location

Clinical Site 1050

New York, New York, 10016, United States

Location

Clinical Site 1019

New York, New York, 10029, United States

Location

Clinical Site 1025

New York, New York, 10065, United States

Location

Clinical Site 1035

The Bronx, New York, 10467, United States

Location

Clinical Site 1010

Valhalla, New York, 10595, United States

Location

Clinical Site 1051

Chapel Hill, North Carolina, 27599, United States

Location

Clinical Site 1032

Durham, North Carolina, 27710, United States

Location

Clinical Site 1058

Greenville, North Carolina, 27834, United States

Location

Clinical Site 1005

Cleveland, Ohio, 44106, United States

Location

Clinical Site 1054

Harrisburg, Pennsylvania, 17105-8700, United States

Location

Clinical Site 1023

Philadelphia, Pennsylvania, 19102, United States

Location

Clinical Site 1021

Providence, Rhode Island, 02903, United States

Location

Clinical Site 1012

Charleston, South Carolina, 29425, United States

Location

Clinical Site 1047

Nashville, Tennessee, 37232, United States

Location

Clinical Site 1029

Houston, Texas, 77030, United States

Location

Clinical Site 1061

San Antonio, Texas, 78215-2035, United States

Location

Clinical Site 1039

San Antonio, Texas, 78229, United States

Location

Clinical Site 1027

Richmond, Virginia, 23298, United States

Location

Clinical Site 1046

Madison, Wisconsin, 53792, United States

Location

Clinical Site 1008

Milwaukee, Wisconsin, 53226, United States

Location

Clinical Site 54163

Buenos Aires, C1425APQ, Argentina

Location

Clinical Site 54164

Córdoba, X5004CDT, Argentina

Location

Clinical Site 61101

Camperdown, New South Wales, 2050, Australia

Location

Clinical Site 61105

Woodville, South Australia, 5011, Australia

Location

Clinical Site 61100

Clayton, Victoria, 3168, Australia

Location

Clinical Site 61104

Parkville, Victoria, 3050, Australia

Location

Clinical Site 61102

Nedlands, Western Australia, 6009, Australia

Location

Clinical Site 61106

Perth, Western Australia, 6000, Australia

Location

Clinical Site 55178

Juiz de Fora, 36036-330, Brazil

Location

Clinical Site 55172

Porto Alegre, Rio Grande Do Sul, 90020-090, Brazil

Location

Clinical Site 55179

Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil

Location

Clinical Site 55175

Ribeirão Preto, 14048-900, Brazil

Location

Clinical Site 55173

Rio de Janeiro, 21041-030, Brazil

Location

Clinical Site 55171

São Paulo, 04038-002, Brazil

Location

Clinical Site 33132

Brest, 29609, France

Location

Clinical Site 33131

Nice, 06002, France

Location

Clinical Site 33136

Saint-Etienne, 42000, France

Location

Clinical Site 33134

Toulouse, 31059, France

Location

Clinical Site 49137

Berlin, 10117, Germany

Location

Clinical Site 49139

Essen, 45122, Germany

Location

Clinical Site 39144

Roma, 00133, Italy

Location

Clinical Site 52184

Aguascalientes, 20230, Mexico

Location

Clinical Site 52181

Cuernavaca, MOR, 62448, Mexico

Location

Clinical Site 52183

Mexico City, 14000, Mexico

Location

Clinical Site 52182

Mexico City, 14080, Mexico

Location

Clinical Site 64112

Auckland, 1142, New Zealand

Location

Clinical Site 64121

Wellington South, 6021, New Zealand

Location

Clinical Site 48151

Bydgoszcz, 85-064, Poland

Location

Clinical Site 48148

Szczecin, 70-111, Poland

Location

Clinical Site 48149

Warsaw, 02-006, Poland

Location

Clinical Site 381140

Belgrade, 11000, Serbia

Location

Clinical Site 381141

Niš, 18000, Serbia

Location

Clinical Site 381142

Novi Sad, 21000, Serbia

Location

Clinical Site 65127

Singapore, 119074, Singapore

Location

Clinical Site 65126

Singapore, 169608, Singapore

Location

Clinical Site 92113

Seoul, 138736, South Korea

Location

Clinical Site 34155

Barcelona, Catalonia, 08003, Spain

Location

Clinical Site 34157

Barcelona, Catalonia, 08035, Spain

Location

Clinical Site 34151

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Clinical Site 46161

Malmo, Sweden

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Christina Sylvest
• Organization: Veloxis Pharmaceuticals

csy@veloxis.com

+4520553877

Study Officials

• Alan Glicklich

  VP, Clinical Operations

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 24, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 18, 2016
• Results First Posted: May 29, 2015

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); AU (6); ME (4); PL (3); SE (1); NZ (2); KR (1); IT (1); US (46); AR (2); ES (3); FR (4); BR (6); DE (2)