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Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients

NCT00765661 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-05-19

Study results available
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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. 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 kidney 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.

Conditions

Interventions

DRUG

Tacrolimus (Tacro™)

The initial dose at 0.14 mg/kg (daily dose for African-American is 0.17 mg/kg), oral in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target tacrolimus trough level of 7 - 20 ng/mL for (PK) phase of the study (through Study Day 14). Post PK maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Other Names: Tacrolimus modified-release

DRUG

Prograf

Prograf® capsules, twice daily: Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Other name: tacrolimus

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • Aptuit

    collaborator INDUSTRY

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00765661 on ClinicalTrials.gov