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Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.

NCT ID: NCT03978494

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2020-05-03

Brief Summary

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

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Detailed Description

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Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.

Conditions

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Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Period 1: Advagraf®; Period 2: Generic tacrolimus

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.

Group Type EXPERIMENTAL

Advagraf®

Intervention Type DRUG

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

Generic tacrolimus

Intervention Type DRUG

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

Period 1: Generic tacrolimus; Period 2: Advagraf®

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.

Group Type EXPERIMENTAL

Advagraf®

Intervention Type DRUG

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

Generic tacrolimus

Intervention Type DRUG

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

Interventions

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Advagraf®

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

Intervention Type DRUG

Generic tacrolimus

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandoz

Role: STUDY_DIRECTOR

Sandoz

Locations

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Sandoz Investigative Site

Grenoble, , France

Site Status

Sandoz Investigative Site

Limoges, , France

Site Status

Sandoz Investigative Site

Nantes, , France

Site Status

Sandoz Investigative Site

Strasbourg, , France

Site Status

Sandoz Investigative Site

Suresnes, , France

Site Status

Sandoz Investigative Site

Toulouse, , France

Site Status

Sandoz Investigative Site

Tours, , France

Site Status

Sandoz Investigative Site

Berlin, , Germany

Site Status

Sandoz Investigative Site

Bochum, , Germany

Site Status

Sandoz Investigative Site

Essen, , Germany

Site Status

Sandoz Investigative Site

Hanover, , Germany

Site Status

Sandoz Investigative Site

Kaiserslautern, , Germany

Site Status

Sandoz Investigative Site

Kiel, , Germany

Site Status

Countries

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France Germany

Other Identifiers

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2018-002672-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1829-TAC-1

Identifier Type: -

Identifier Source: org_study_id

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