A multi-center non-interventional study (NIS) to assess practicability, effectiveness and tolerability of once daily applied tacrolimus formulations used in kidney transplant patients.

A multi-center non-interventional study (NIS) to assess practicability, effectiveness and tolerability of once daily applied tacrolimus formulations used in kidney transplant patients. - TACRONIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011124

Enrollment

120

Registered

2016-11-11

Start date

2017-02-24

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Immunosuppression after kidney transplantation Z94

Interventions

Group 1: Envarsus® (tacrolimus) prolonged-release tablets once daily, orally, provided in 0.75-, 1-, and 4-mg dose strengths. Group 2: Advagraf® (tacrolimus) prolonged-release hard capsules once dai

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult male or female kidney transplant recipients 0-10 days after transplantation with an indication for immunosuppression therapy according to the latest Envarsus®/Advagraf® SmPC. 2. Treatment with once daily tacrolimus at time of inclusion into the study. Patients must have received at least the first dose of once daily tacrolimus prior to giving consent. 3. Patient’s signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients will be excluded from the study according to contraindications, restrictions and precautions described in the Envarsus®/Advagraf® SmPC. 2. Recipients of any transplanted organ other than kidney. 3. Recipients positive for HIV.

Design outcomes

Primary

Measure	Time frame
- To assess initial dosing, blood levels, dosing patterns, and dose adjustments of once daily tacrolimus (Envarsus®/Advagraf®) (according to what is measured on a standard basis).	—

Secondary

Measure	Time frame
- To determine tolerability profile of once daily tacrolimus over 6 months (Documentation of Adverse Events). - To determine effectiveness of once daily tacrolimus over 6 months (Tacrolimus trough levels, time to reach Tacrolimus standard reference range, number of dose adjustments, Tacrolimus total daily dose, treatment failure rate, time to treatment failure, time to treatment discontinuation, incidence of death - graft failure - BPAR - loss to follow-up, concomitant medications, laboratory parameters (AST, ALT, AP, eGFR)).	—

Measure

Time frame

- To determine tolerability profile of once daily tacrolimus over 6 months (Documentation of Adverse Events). - To determine effectiveness of once daily tacrolimus over 6 months (Tacrolimus trough levels, time to reach Tacrolimus standard reference range, number of dose adjustments, Tacrolimus total daily dose, treatment failure rate, time to treatment failure, time to treatment discontinuation, incidence of death - graft failure - BPAR - loss to follow-up, concomitant medications, laboratory parameters (AST, ALT, AP, eGFR)).

—

Countries

Germany

Contacts

Public ContactChristoph Maas

Chiesi GmbH

c.maas@chiesi.com+49 40 89724 309

Outcome results

None listed

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