Anti-donor alloreactivity-guided CNI minimization versus unguided standard triple therapy in living-donor kidney transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002465-28-DE

Enrollment

100

Registered

2015-11-11

Start date

2016-02-19

Completion date

Unknown

Last updated

2021-03-17

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

Conditions

Renal transplantation MedDRA version: 20.0 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865

Interventions

Trade Name: Advagraf Product Name: Tacrolimus Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent obtained. 2. Male or female subject = 18 years old 3. Recipient of a primary renal transplant from a living unrelated, living related non-human leukocyte antigen identical donor 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to tacrolimus or other macrolides or to any of the components of the planned study treatment 2. Immunized patients with a current PRA > 5% 3. Recipient of ABO incompatible allograft or CDC crossmatch positive transplant

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of an anti-donor alloreactivity guided CNI minimization on the evolution of renal function;Secondary Objective: Further objectives are to evaluate the effects on BPAR, graft loss or death and the composite efficacy failure rate, to compare the safety and to explore influences of immunological parameters.;Primary end point(s): Renal function calculated by the MDRD-4 formula;Timepoint(s) of evaluation of this end point: At 12 months after transplantation	—

Measure

Time frame

Main Objective: To evaluate the effect of an anti-donor alloreactivity guided CNI minimization on the evolution of renal function;Secondary Objective: Further objectives are to evaluate the effects on BPAR, graft loss or death and the composite efficacy failure rate, to compare the safety and to explore influences of immunological parameters.;Primary end point(s): Renal function calculated by the MDRD-4 formula;Timepoint(s) of evaluation of this end point: At 12 months after transplantation

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Secondary

Measure	Time frame
Secondary end point(s): The incidence of graft loss The incidence of death The incidence of tBPAR Composite efficacy failure rate of treated biopsy proven acute rejection (tBPAR), graft loss or death and eGFR < 50 ml/min/1.72m2 Further renal function parameters (S-Krea, Cockroft-Gault, Nankivell, CKD-Epi) Frequency and severity of adverse events and adverse events leading to study discontinuation;Timepoint(s) of evaluation of this end point: up to 12 months after transplantation	—

Measure

Time frame

Secondary end point(s): The incidence of graft loss The incidence of death The incidence of tBPAR Composite efficacy failure rate of treated biopsy proven acute rejection (tBPAR), graft loss or death and eGFR < 50 ml/min/1.72m2 Further renal function parameters (S-Krea, Cockroft-Gault, Nankivell, CKD-Epi) Frequency and severity of adverse events and adverse events leading to study discontinuation;Timepoint(s) of evaluation of this end point: up to 12 months after transplantation

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Countries

Germany

Contacts

Public ContactKCS Chirurgie

Klinik für Allgemeine-, Viszeral-, und Transplantationschirurgie, Klinikum der Universität München

kcs@med.uni-muenchen.de+49894400-0

Outcome results

None listed

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