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

Phase 4

Completed

• Conditions: Organ or Tissue Transplant; Complications
• Interventions: Drug: ADVAGRAF®; Drug: ENVARSUS®

• Registration Number: NCT02500212
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADVAGRAF capsules	ADVAGRAF®	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
ENVARSUS tablets	ENVARSUS®	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

Primary Outcome Measures

Name	Time	Method
Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL	pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose

Secondary Outcome Measures

Name	Time	Method
Heart Rate, (beats per minute)	before dosing
Serum creatinine (mg/dL)	before dosing
estimated glomerular filtration rate (eGFR) mL/min;	before dosing
Qt (milliseconds)	before dosing
Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL	24.0 hr post-dose	Whole blood trough drug concentration 24hour post dose

Trial Locations

Locations (7)

Clinique de Nephrologie CHU Grenoble; 🇫🇷 Grenoble, France

Nephrology department CHU de Saint-Etienne Hospital Nord; 🇫🇷 Saint Etienne, France

Service de Nephrologie; 🇫🇷 Montpellier, France

Unité de transplantation rénale -Hopital Pasteur; 🇫🇷 Nice, France

CHU Rangueil, 1 avenue J Poulhes TSA 50032.; 🇫🇷 Toulouse, France

Nephrology Department Hopital La Cavale Blanche; 🇫🇷 Brest, France

CHU Limoges; 🇫🇷 Limoges, France