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

Study Identifier:
CCD-06235AA1-02
ClinicalTrials.gov Identifier:
NCT02500212
EudraCT Identifier:
2014-005572-28
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Prophylaxis of Kidney Rejection
Study Drug
  • Drug: ENVARSUS®
  • Drug: ADVAGRAF®
Date
Jul 2015 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Nephrology Department Hopital La Cavale Blanche
Brest, France, 296009
Status
N/A
Location
Clinique de Nephrologie CHU Grenoble
Grenoble, France, 38043
Status
N/A
Location
CHU Limoges
Limoges, France, 87042
Status
N/A
Location
Service de Nephrologie
Montpellier, France, 34295
Status
N/A
Location
Unité de transplantation rénale -Hopital Pasteur
Nice, France
Status
N/A
Location
Nephrology department CHU de Saint-Etienne Hospital Nord
Saint Etienne, France, 42055
Status
N/A

Study Publications

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 Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.