Alkaline Phosphatase to prevent ischemia reperfusion injury in living kidney transplantatio

Phase 1

• Conditions: Ischemia reperfusion injury in living donor kidney transplantation; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-004737-85-NL
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Age >18
-Recipients of a living donor kidney
-First organ transplanation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Second or subsequent organ transplantation
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study whether exogenous alkaline phosphatase improves renal function at 1 year by decreasing IRI short after transplantation.<br>Safety;Secondary Objective: To study whether exogenous alkaline phosphatase administered early in living donor kidney transplantation will:<br>(1)Improve eGFR at 3 months after transplantation<br>(2)Improved ‘rate of fall’ in creatinin at 72 hours after transplantation<br>(3)Dampen the release of pro-inflammatory cytokines (IL6, IL8, TNFa) in the first 24 hours<br>(4)Be associated with a decrease in the ‘urinary damage markers’ (retinol-binding protein, KIM1, NGAL).;Primary end point(s): Graft function at one year after kidney transplantation (iohexol clearance);Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): oeGFR and 24 hour urine creatinine clearance at 3 months<br>oRate of fall in creatinin in the first 72 hours after transplantation<br>oCytokine profiles in peripheral blood samples<br>oUrinary ‘kidney damage markers’: retinol binding protein; KIM1; NGAL <br>oIncidence of biopsy proven rejection<br>;Timepoint(s) of evaluation of this end point: First week<br>3 months