A low-dose immunosuppression protocol in lung transplantatio

Phase 1

Conditions: ung Transplantation
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2018-001680-24-AT

Lead Sponsor: Medical University of Vienna - Abteilung für Thoraxchirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -Primary Objective<br>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.<br>;Secondary Objective: - Secondary Objectives<br>To assess impact of the proposed protocol on:<br>Freedom from ACR<br>Freedom from CLAD two years after transplantation<br>Overall survival<br>Occurrence of de novo donor-specific antibodies (DSA)<br>Incidence of CMV infections<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Freedom from ACR<br>Freedom from CLAD two years after transplantation<br>Overall survival<br>Occurrence of de novo donor-specific antibodies (DSA)<br>Occurrence of CMV infections<br>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