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

Chiesi Farmaceutici S.p.A.75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Organ or Tissue Transplant; Complications

Interventions

ENVARSUS®DRUG

ADVAGRAF®DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (7)

Nephrology Department Hopital La Cavale Blanche

Brest, France

Clinique de Nephrologie CHU Grenoble

Grenoble, France

CHU Limoges

Limoges, France

Service de Nephrologie

Montpellier, France

Outcomes

Primary Outcomes

Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL

Time frame: 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 Outcomes

Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL

Whole blood trough drug concentration 24hour post dose

Time frame: 24.0 hr post-dose

Serum creatinine (mg/dL)

Time frame: before dosing

estimated glomerular filtration rate (eGFR) mL/min;

Time frame: before dosing

Heart Rate, (beats per minute)

Time frame: before dosing

Qt (milliseconds)

Time frame: before dosing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.