Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-06-30

Brief Summary

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Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.

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Detailed Description

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Conditions

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Organ or Tissue Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ENVARSUS tablets

Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths.

Envarsus® tablets will be administered orally once daily in the morning

Group Type EXPERIMENTAL

ENVARSUS®

Intervention Type DRUG

ADVAGRAF capsules

Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths.

Advagraf® capsules will be administered orally once daily in the morning

Group Type ACTIVE_COMPARATOR

ADVAGRAF®

Intervention Type DRUG

Interventions

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ENVARSUS®

Intervention Type DRUG

ADVAGRAF®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recipients of a kidney transplant from a deceased donor or a living donor

Exclusion Criteria

* Recipient of any transplanted organ other than a kidney;
* Recipients of a bone marrow or stem cell transplant;
* Recipients of a kidney from a cardiac death donor;
* Recipients of a kidney from an ABO incompatible donor;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No