Skip to content

Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function in deceased donor kidney transplantation

Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function in deceased donor kidney transplantation - APhIRI II

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51462
Enrollment
70
Registered
2022-08-16
Start date
2023-05-22
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

acute kidney damage acute kidney injury

Interventions

30,000IU of bRESCAP or placebo

Sponsors

Nefrologie
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age > 18 - Recipients of a donor awaiting cardiac death on the intensive care (definition of a donor cardiac death type III according to the *Maastricht classification*) - Written informed consent

Exclusion criteria

Exclusion criteria: - Strict vegetarians or vegans - History of allergy to bovine proteins

Design outcomes

Secondary

MeasureTime frame
- Mean duration of hospitalization after kidney transplantation - Incidence of persistent dialysis DGF (> 14 days) - Incidence of DGF using functional and dialysis definition and a combination of the two - Duration of DGF using functional and dialysis definition and a combination of the two - Dall of serum creatinine in the first week after transplantation - Kidney perfusion contrast renography at day 6 - Creatinine clearance at 3 months and 1 year after transplantation - Proteinuria at 3 months and 1 year after transplantation - Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation - Primary non-function (defined as dialysis dependency or creatinine clearance

Primary

MeasureTime frame
- Difference between treatment and placebo group in duration of delayed graft failure (DGF). DGF is defined as need for dialysis, excluding short sessions for hyperkalemia. DGF is defined as need for dialysis, excluding single sessions for hyperkalemia.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)