Comparison of pharmacokinetic (PK) levels before and after conversion from tacrolimus to extended-release tacrolimus (ENVARSUS®) in diabetic transplant recipients"

Comparison of pharmacokinetic (PK) levels before and after conversion from twice-daily tacrolimus to once-daily extended-release tacrolimus (LCPT) in diabetic transplant recipients - SPK-PK

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003602-27-FR

Enrollment

Registered

2020-01-27

Start date

2020-07-23

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simultaneous Pancreas Kidney Transplant, Diabetic recipients of transplants

Interventions

Trade Name: Envarsus 0.75 mg prolonged-release tablets Pharmaceutical Form: Tablet Trade Name: Envarsus 1 mg prolonged-release tablets Pharmaceutical Form: Tablet Trade Name: Envarsus 4 mg prolon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patient is willing and able to give informed consent for participation in the trial. • Male or Female, aged 18 years or above. • Recipient of kidney and pancreas-transplant • Both transplants are functioning at time of PK profile measurements • Standard immunosuppressive therapy has been started post-operatively, in accordance with local policy, including tacrolimus. • In the Investigator’s opinion, is able and willing to comply with all trial requirements. • Patients with social security. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Patient is inappropriate for standard immunosuppressive therapy. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial. • Concomitant therapy with drugs potentially interfering with tacrolimus pharmacokinetics, especially those interfering with CYP3A4 (see 4.4 section in tacrolimus / l’ENVARSUS® summary of product characteristics). • Pregnant or breast-feeding women and female patient with potential childbearing refusing contraception. • Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship.

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterise the PK profile of extended release tacrolimus (Envarsus) in diabetic transplant recipients, and compare it to the PK profile of tacrolimus.;Secondary Objective: - Further quantification of the PK profile of extended release tacrolimus - Assessment of biological and clinical tolerance/ safety;Primary end point(s): AUC0-24;Timepoint(s) of evaluation of this end point: Day 13-18 after surgery	—

Measure

Time frame

Main Objective: To characterise the PK profile of extended release tacrolimus (Envarsus) in diabetic transplant recipients, and compare it to the PK profile of tacrolimus.;Secondary Objective: - Further quantification of the PK profile of extended release tacrolimus - Assessment of biological and clinical tolerance/ safety;Primary end point(s): AUC0-24;Timepoint(s) of evaluation of this end point: Day 13-18 after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): - Cmin, Cmax, Cavg, Tmax, Ke, t1/2, % fluctuation. - Incidence of serious adverse events;Timepoint(s) of evaluation of this end point: - Day 13-18 after surgery - 3 months after surgery	—

Countries

France

Contacts

Public ContactDirection recherche, CHU de Nantes

CHU de Nantes

bp-prom-regl@chu-nantes.fr33(0)253482835

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026