A low-dose immunosuppression protocol in lung transplantation

Combined low-dose everolimus and low-dose tacrolimus after alemtuzumab induction therapy: a randomized prospective trial in lung transplantation - ALiKE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001680-24-AT

Enrollment

110

Registered

2018-06-27

Start date

2018-09-12

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

Lung Transplantation

Interventions

Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Tacrolimus monohydrate Other descriptive name: TACROLIMUS MONOHYDRATE Pharmaceutical Form: Prolonged-release tablet INN or Proposed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All bilateral lung transplantation Age > 18 years 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

Exclusion criteria: Pediatric patients (age < 18 years) Pre-transplant colonization of Burkholderia or resistant Mycobacterium abscessus Wound infection at the time of randomization Inclusion in other studies

Design outcomes

Primary

Measure	Time frame
Main Objective: -Primary Objective To analyze the effect of the combined use of low-dose everolimus and low-dose tacrolimus after alemtuzumab induction therapy on kidney function, measured as eGFR. ;Secondary Objective: - Secondary Objectives To assess impact of the proposed protocol on: Freedom from ACR Freedom from CLAD two years after transplantation Overall survival Occurrence of de novo donor-specific antibodies (DSA) Incidence of CMV infections Other comorbidities (hypertension, dyslipidemia, diabetes, tremor);Primary end point(s): eGFR two years after transplantation;Timepoint(s) of evaluation of this end point: 0, 3, 6, 12 and 24 months after lung transplantation	—

Measure

Time frame

Main Objective: -Primary Objective To analyze the effect of the combined use of low-dose everolimus and low-dose tacrolimus after alemtuzumab induction therapy on kidney function, measured as eGFR. ;Secondary Objective: - Secondary Objectives To assess impact of the proposed protocol on: Freedom from ACR Freedom from CLAD two years after transplantation Overall survival Occurrence of de novo donor-specific antibodies (DSA) Incidence of CMV infections Other comorbidities (hypertension, dyslipidemia, diabetes, tremor);Primary end point(s): eGFR two years after transplantation;Timepoint(s) of evaluation of this end point: 0, 3, 6, 12 and 24 months after lung transplantation

—

Secondary

Measure	Time frame
Secondary end point(s): Freedom from ACR Freedom from CLAD two years after transplantation Overall survival Occurrence of de novo donor-specific antibodies (DSA) Occurrence of CMV infections Occurrence of other comorbidities (hypertension, dyslipidemia, diabetes, tremor);Timepoint(s) of evaluation of this end point: 0, 3, 6, 12 and 24 months after lung transplantation	—

Countries

Austria

Contacts

Public ContactMedical University of Vienna

Division of Thoracic surgery, Medical University of Vienna

004314040056400

Outcome results

None listed

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