NCT00772148

Brief Summary

The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney and liver. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is an investigational drug. This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a liver transplant in patients randomly assigned (by chance, like flipping a coin) to take either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In addition, patients will remain on study drug for 360 days in order to evaluate the relative safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

June 25, 2015

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

October 14, 2008

Results QC Date

May 12, 2015

Last Update Submit

June 2, 2015

Conditions

Liver Failure

Keywords

LiverHepaticTransplantationImmunosuppressionTacrolimusPrograf

Outcome Measures

Primary Outcomes (5)

  • Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.

    The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.

    14 days

  • Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.

    The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.

    14 days

  • Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.

    Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.

    1 day

  • Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.

    Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.

    7 days

  • Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.

    Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.

    14 days

Secondary Outcomes (1)

  • Number of Participants Who Died Within the 360 Days.

    360 days

Study Arms (2)

LCP-Tacro

EXPERIMENTAL

LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)

Drug: LCP -Tacro

Prograf (tacrolimus)

ACTIVE COMPARATOR

Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)

Drug: Prograf

Interventions

LCP -TacroDRUG

LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL. Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)

Also known as: tacrolimus
LCP-Tacro
PrografDRUG

Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL. Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)

Also known as: tacrolimus
Prograf (tacrolimus)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men and women at least 18 years of age who are recipients of a liver transplant from a deceased donor with a Model for End-Stage Liver Disease (MELD) score at the time of transplantation of ≤ 30 who are able to give informed consent for participation

You may not qualify if:

  • Recipient of any transplanted organ other than a liver
  • Recipients of a liver from a non-heart beating donor
  • Recipients of a liver from an ABO incompatible donor
  • Recipients of a bone marrow or stem cell transplant
  • Patients with a white blood cell count ≤ 2.8 x 109/L unless the absolute neutrophil count (ANC) is \> 1.0 x 109/L
  • Patients who fail a drugs of abuse screen in the pre-transplant evaluation
  • Patients unable to swallow study medication
  • Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol
  • Pregnant or nursing women (women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication)
  • Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception throughout the duration of the study
  • Patients who were treated with any other investigational agent in the 30 days prior to enrollment
  • Patients seropositive for human immunodeficiency virus (HIV)
  • Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully, or hepatocellular carcinoma (HCC) that meet the Milan Criteria for liver transplantation
  • Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
  • Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LifeLink Healthcare Institute

Tampa, Florida, 33606, United States

Location

Related Publications (1)

  • DuBay DA, Teperman L, Ueda K, Silverman A, Chapman W, Alsina AE, Tyler C, Stevens DR. Pharmacokinetics of Once-Daily Extended-Release Tacrolimus Tablets Versus Twice-Daily Capsules in De Novo Liver Transplant. Clin Pharmacol Drug Dev. 2019 Nov;8(8):995-1008. doi: 10.1002/cpdd.657. Epub 2019 Jan 22.

    PMID: 30667591DERIVED

MeSH Terms

Conditions

Liver Failure

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Christina Sylvest
Organization
Veloxis Pharmaceuticals
csy@veloxis.com
+45 20553877

Study Officials

  • Angel Alsina, M.D.

    Tampa General Hospital, LifeLink Healthcare Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 25, 2015

Results First Posted

June 25, 2015

Record last verified: 2015-06

Locations

US(1)