Alkaline Phosphatase to prevent ischemia reperfusion injury in living kidney transplantation

Alkaline Phosphatase to prevent ischemia reperfusion injury in living kidney transplantation - APhIRI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50363

Enrollment

Registered

2018-08-28

Start date

2019-05-27

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

Ischemia reperfusion injury in kidney transplantation

Interventions

The intervention group will be treated with either alkaline phosphatase or placebo at the induction of transplantation, followed by continuous infusion for 24 hours. This treatment will be on top of

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >18 - Recipients of a living donor kidney

Exclusion criteria

Exclusion criteria: - Strict vegetarians or veganists. These individuals have higher potential risk to an allergic reaction to the infused bovine protein. - History of allergy to bovine proteins - Not standard immunosuppression at time of transplantation (see protocol)

Design outcomes

Primary

Measure	Time frame
- Graft function 12 months after kidney transplantation (eGFR and iohexol clearance) - Safety outcome:% infusion related reactions/ side effects	—

Secondary

Measure	Time frame
- eGFR and creatinine clearance at 3 months - Rate of fall in creatinin in the first 48 hours after transplantation - Cytokine profiles in peripheral blood samples - Urinary kidney damage markers: retinolbinding protein; KIM1; NGAL ; (assay NephroCheck) - Incidence of biopsy proven rejection	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)