Rescue Alkaline Phosphatase In Defense against all cause Acute Kidney Injury

Rescue Alkaline Phosphatase In Defense against all cause Acute Kidney Injury - RAPID-AKI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51165

Enrollment

300

Registered

2021-11-04

Start date

2022-04-29

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

acute kidney injury

Interventions

The intervention group will be treated with a bolus of 1000 international units (IU) bovine rescue alkaline phosphatase (bRESCAP manufactured by Alloksys Life Sciences), followed by continuous infus

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosed with AKI Stage 2 or 3 • Age 18 years and older • Written informed consent by patient or representative

Exclusion criteria

Exclusion criteria: • History of allergy to bovine proteins or strict vagan-/vegetarian diet • Chronic kidney disease with a baseline eGFR

Design outcomes

Primary

Measure	Time frame
Primary outcome: - Proportion of patients that develop acute kidney disease (AKD) as defined by Acute Disease Quality Initiative (ADQI) 16 workgroup combined with 90 day mortality.	—

Secondary

Measure	Time frame
Secondary outcomes: - Safety of administration of exogenous AP in the context of AKI (infusion related reactions and side-effects) - Renal function in treatment and placebo group at day 1-7, 28 and 90 and at 1 year. - 90 day mortality in treatment group vs placebo group - Microvascular endpoints: angiopoietin 1-2 ratio, S renal residual capacity	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)