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

Chiesi

Status and phase: Completed; Phase 4

Conditions: Organ or Tissue Transplant; Complications

Treatments: Drug: ENVARSUS®; Drug: ADVAGRAF®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02500212

CCD-06235AA1-02

2014-005572-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

ENVARSUS tablets

Experimental group

Description:

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

Treatment:

Drug: ENVARSUS®

ADVAGRAF capsules

Active Comparator group

Description:

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

Treatment:

Drug: ADVAGRAF®