Acute Kidney Injury Clinical Trial
Official title:
A DB Four-Arm, Parallel Group, Proof of Concept, Dose-Finding Adaptive Phase 2a/2b RCT to Investigate the Safety, Tolerability and Efficacy and Effect on QoL of Human Recombinant Alkaline Phosphatase in Patients With Sepsis-Associated AKI
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
Design:
Adaptive trial with two stages and interim analysis
- Stage 1: four arms; three dose groups and placebo. n=30/arm. (n=120)
- Interim analysis based on 120 subjects, with continued recruitment, adding 11 subjects
to Stage 1 safety population (n=131): to evaluate safety and select dose for stage 2
- Stage 2: one dose group and placebo. N=85/arm. (n=170) Total n in the study: 301.
Primary objectives
- To investigate the effect of recAP on renal function (measured creatinine clearance
D1-D7 period, incidence and duration of renal replacement therapy (RRT) over 28 days,
eGFR at D60 and D90) and related clinical parameters (ICU stay, Hospital stay,
Mechanical ventilation over 28 days, SOFA and SAPS2 scores 28 days) in patients with
SA-AKI.
- To determine effective therapeutic dose(s) of recAP.
Secondary objectives
- To investigate the safety and tolerability of recAP in patients with SA AKI. (assessed
by independent Data Monitoring Board, adverse events over 90 days study period,
laboratory values, ECG, physical examniations, vital signs, Anti Drug Antibodies)
- To investigate the pharmacokinetic profile (PK) of recAP in a subset of patients (part
1, n=120) with SA AKI. (Population PK; AUC D1-7, Cmax, Cmin, Tmax, terminal T1/2)
- To investigate the immunogenic potential of recAP in patients with SA AKI. (anti-drug
antibodies at D14, D28, D60 and D90)
- To investigate the effect on quality of life (using the EuroQol, EQ-5D) following study
inclusion, at ICU discharge, and Day 90.
Other objectives
• To evaluate whether specific patient groups can be identified that benefit most from recAP
treatment or patient groups that are non-responders
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