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

Sandoz

Status and phase: Withdrawn; Phase 1

Conditions: Kidney Transplant

Treatments: Drug: Generic tacrolimus; Drug: Advagraf®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03978494

1829-TAC-1

2018-002672-40 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Period 1: Advagraf®; Period 2: Generic tacrolimus

Experimental group

Description:

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.

Treatment:

Drug: Advagraf®

Drug: Generic tacrolimus

Period 1: Generic tacrolimus; Period 2: Advagraf®

Experimental group

Description:

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.

Treatment:

Drug: Advagraf®

Drug: Generic tacrolimus