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

NCT01187953 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2016-05-18

Study results available
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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

Interventions

DRUG

Prograf (tacrolimus)

Administered per current product labeling

DRUG

LCP-Tacro

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.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Alan Glicklich · VP, Clinical Operations

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-03-31
Completion
2014-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • France
  • Germany
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Sweden

Study Locations

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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 NCT01187953 on ClinicalTrials.gov