Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant

Phase 2

Completed

• Conditions: Renal Failure
• Interventions: Drug: LCP-Tacro tablets; Drug: Prograf

• Registration Number: NCT01666951
• Lead Sponsor: Veloxis Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Detailed Description

This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Study Start: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Results First Submitted: 2015-05-19
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-30
• Last Update Submitted: 2015-06-30
• Results First Posted: 2015-07-07
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCP-Tacro	LCP-Tacro tablets	LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
Prograf	Prograf	Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation	28 days	The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation	28 days	The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation	28 days	The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation	28 days	The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.

Trial Locations

Locations (13)

Clinical Investigative Site 000002; 🇺🇸 Tampa, Florida, United States

Clinical Investigative Site 00008; 🇺🇸 Cleveland, Ohio, United States

Clinical Investigative Site 000005; 🇺🇸 Lexington, Kentucky, United States

Clinical Investigative Site 00004; 🇺🇸 Aurora, Colorado, United States

Clinical Investigative Site 000009; 🇺🇸 Ann Arbor, Michigan, United States

Clinical Investigative Site 00006; 🇺🇸 New York, New York, United States

Clinical Investigative Site 000010; 🇺🇸 Livingston, New Jersey, United States

Clinical Investigative Site 000013; 🇺🇸 Dallas, Texas, United States

Clinical Investigative Site 000011; 🇺🇸 Buffalo, New York, United States

Clinical Investigative Site 000015; 🇺🇸 San Diego, California, United States

Clinical Investigative Site 000012; 🇺🇸 San Francisco, California, United States

Clinical Investigative Site 00003; 🇺🇸 Philadelphia, Pennsylvania, United States

Clinical Investigative Site 00001; 🇺🇸 Charlottesville, Virginia, United States