Primary Graft Dysfunction (PGD) after lung transplantation
Conditions
Interventions
Product Name: AP301
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: AP301
Current Sponsor code: AP301
Other descriptive name: AP301
Concentration unit: mg milligram(s)
Concentr
Sponsors
Apeptico Forschung und Entwicklung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Being a male or female recipient on the AKH`s waiting list for primary single or double LuTX PGD score = 1 within 72 hours after LuTX Informed consent is available 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product Postoperative ECMO support Paediatric /adolescent recipients (< 18 years) Lobar transplantation Retransplantation Combined solid organ transplants Participation in other drug trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) according to ISHLT (International Society for Heart and Lung Transplantation) criteria in patients after primary LuTX in comparison to placebo. Secondary Objectives ;Secondary Objective: To assess: • recipient mortality at 30 days after transplantation (%), • duration of intubation • requirement of mechanical ventilation, • length of ICU stay, • incidence of acute rejections, • freedom of chronic lung allograft dysfunction (CLAD), • graft survival within 30 days, • local and systemic safety and tolerability of AP301.;Primary end point(s): The primary efficacy variable will be the changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient.;Timepoint(s) of evaluation of this end point: 72 hours after diagnosis of PGD | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Oxygenation index until day 7 of treatment or until extubation. 2. EVWL (measured with PiCCO® technique) until day 7 of treatment 3. Changes in ?pO2 during treatment 4. recipient mortality at 30 days after transplantation (%), 5. duration of intubation 6. requirement of mechanical ventilation, 7. length of ICU stay, 8. incidence of acute rejections, 9. freedom of chronic lung allograft dysfunction (CLAD) 10. graft survival within 30 days 11. overall survival within 30 days ;Timepoint(s) of evaluation of this end point: up to 7 days after diagnosis | — |
Countries
Austria
Contacts
Public ContactHead of Company
Apeptico Forschung und Entwicklung GmbH
Outcome results
None listed