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

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

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Source 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.

Overall Status Completed
Start Date July 2015
Completion Date June 2016
Primary Completion Date June 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL 24.0 hr post-dose
Serum creatinine (mg/dL) before dosing
estimated glomerular filtration rate (eGFR) mL/min; before dosing
Heart Rate, (beats per minute) before dosing
Qt (milliseconds) before dosing
Enrollment 75
Condition
Intervention

Intervention type: Drug

Intervention name: ENVARSUS®

Arm group label: ENVARSUS tablets

Intervention type: Drug

Intervention name: ADVAGRAF®

Arm group label: ADVAGRAF capsules

Eligibility

Criteria:

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;

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Nephrology Department Hopital La Cavale Blanche
Clinique de Nephrologie CHU Grenoble
CHU Limoges
Service de Nephrologie
Unité de transplantation rénale -Hopital Pasteur
Nephrology department CHU de Saint-Etienne Hospital Nord
CHU Rangueil, 1 avenue J Poulhes TSA 50032.
Location Countries

France

Verification Date

February 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: ENVARSUS tablets

Arm group type: Experimental

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

Arm group label: ADVAGRAF capsules

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov