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

Organ or Tissue Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500212
• Other study ID #: CCD-06235AA1-02
• Secondary ID: 2014-005572-28
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Organ or Tissue Transplant; Complications

Intervention

Drug:
• ENVARSUS®

• ADVAGRAF®

Locations

Country	Name	City	State
France	Nephrology Department Hopital La Cavale Blanche	Brest
France	Clinique de Nephrologie CHU Grenoble	Grenoble
France	CHU Limoges	Limoges
France	Service de Nephrologie	Montpellier
France	Unité de transplantation rénale -Hopital Pasteur	Nice
France	Nephrology department CHU de Saint-Etienne Hospital Nord	Saint Etienne
France	CHU Rangueil, 1 avenue J Poulhes TSA 50032.	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France, 

References & Publications (1)

Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney T — View Citation

Outcome

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

External Links

•   Study Record on EU Clinical Trials Register including results