NCT03978494

Brief Summary

Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_1

Geographic Reach
2 countries

13 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2020

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

June 5, 2019

Last Update Submit

September 12, 2019

Conditions

Kidney Transplant

Keywords

Kidney transplant; Renal transplant

Outcome Measures

Primary Outcomes (2)

  • AUC(0-τ)ss

    Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state

    Day 21 of each treatment period

  • Cmax,ss

    Maximum whole blood concentration at steady state

    Day 21 of each treatment period

Secondary Outcomes (10)

  • AUC(0-τ)ss

    Day 14 of each treatment period

  • Cmax,ss

    Day 14 of each treatment period

  • Cmin,ss

    Days 14 and 21 of each treatment period

  • Cτ,ss

    Days 14 and 21 of each treatment period

  • Cav

    Days 14 and 21 of each treatment period

  • +5 more secondary outcomes

Study Arms (2)

Period 1: Advagraf®; Period 2: Generic tacrolimus

EXPERIMENTAL

In Period 1 patients will receive branded tacrolimus (Advagraf®) orally once-a-day and in Period 2 patients will receive the generic tacrolimus (Sandoz) orally once-a-day.

Drug: Advagraf®Drug: Generic tacrolimus

Period 1: Generic tacrolimus; Period 2: Advagraf®

EXPERIMENTAL

In Period 1 patients will receive the generic tacrolimus (Sandoz) orally once-a-day and in Period 2 patients will receive branded tacrolimus (Advagraf®) orally once-a-day.

Drug: Advagraf®Drug: Generic tacrolimus

Interventions

Advagraf®DRUG

Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).

Period 1: Advagraf®; Period 2: Generic tacrolimusPeriod 1: Generic tacrolimus; Period 2: Advagraf®
Generic tacrolimusDRUG

Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)

Period 1: Advagraf®; Period 2: Generic tacrolimusPeriod 1: Generic tacrolimus; Period 2: Advagraf®

Eligibility Criteria

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

You may qualify if:

  • Male or female patients aged ≥18 years;
  • Patients with a Body Mass Index (BMI) included in the interval \[18.5-33.0\] kg/m²;
  • Patients who received a primary kidney transplant at least 12 months prior to study entry

You may not qualify if:

  • Evidence or suspicion of ongoing or persistent, acute or chronic rejection;
  • Requirement for dialysis within the six months prior to study entry;
  • Glomerular filtration rate (GFR) \<30 mL/min
  • Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;
  • Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sandoz Investigative Site

Grenoble, France

Location

Sandoz Investigative Site

Limoges, France

Location

Sandoz Investigative Site

Nantes, France

Location

Sandoz Investigative Site

Strasbourg, France

Location

Sandoz Investigative Site

Suresnes, France

Location

Sandoz Investigative Site

Toulouse, France

Location

Sandoz Investigative Site

Tours, France

Location

Sandoz Investigative Site

Berlin, Germany

Location

Sandoz Investigative Site

Bochum, Germany

Location

Sandoz Investigative Site

Essen, Germany

Location

Sandoz Investigative Site

Hanover, Germany

Location

Sandoz Investigative Site

Kaiserslautern, Germany

Location

Sandoz Investigative Site

Kiel, Germany

Location

Study Officials

  • Sandoz

    Sandoz

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 7, 2019

Study Start

September 2, 2019

Primary Completion

May 3, 2020

Study Completion

May 3, 2020

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)FR(7)