Alkaline Phosphatase to prevent ischemia reperfusion injury in living kidney transplantatio

Phase 3

Completed

• Conditions: Ischemia reperfusion injury in kidney transplantation; 10038430; 10038365

• Registration Number: NL-OMON50363
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Age >18
- Recipients of a living donor kidney

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Graft function 12 months after kidney transplantation (eGFR and iohexol<br /><br>clearance)<br /><br>- Safety outcome:% infusion related reactions/ side effects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- eGFR and creatinine clearance at 3 months<br /><br>- *Rate of fall in creatinin* in the first 48 hours after transplantation<br /><br>- Cytokine profiles in peripheral blood samples<br /><br>- Urinary *kidney damage markers*: retinolbinding protein; KIM1; NGAL ; (assay<br /><br>NephroCheck)<br /><br>- Incidence of biopsy proven rejection</p><br>