NCT02500212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 7, 2015

Last Update Submit

July 30, 2020

Conditions

Organ or Tissue Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

ENVARSUS tablets

EXPERIMENTAL

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

Drug: ENVARSUS®

ADVAGRAF capsules

ACTIVE COMPARATOR

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

Drug: ADVAGRAF®

Interventions

ENVARSUS®DRUG
ENVARSUS tablets
ADVAGRAF®DRUG
ADVAGRAF capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients of a kidney transplant from a deceased donor or a living donor

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Nephrology Department Hopital La Cavale Blanche

Brest, 296009, France

Location

Clinique de Nephrologie CHU Grenoble

Grenoble, 38043, France

Location

CHU Limoges

Limoges, 87042, France

Location

Service de Nephrologie

Montpellier, 34295, France

Location

Unité de transplantation rénale -Hopital Pasteur

Nice, France

Location

Nephrology department CHU de Saint-Etienne Hospital Nord

Saint-Etienne, 42055, France

Location

CHU Rangueil, 1 avenue J Poulhes TSA 50032.

Toulouse, 31400, France

Location

Related 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 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.

    PMID: 30552587RESULT

Related Links

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

FR(7)