ear-infrared fluorescence imaging in kidney transplantations using ZW800-1 for perfusion assessment: a pilot study

Phase 2

Completed

Conditions: Kidney and ureters
10038430
10038365

Registration Number: NL-OMON46729

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1) Patients > 18 years old;
2) Patient couples scheduled for a living donor nephrectomy and kidney transplantation;
3) Patients should be capable and willing to give informed consent before study specific procedures;
4) No unacceptable known cardiovascular or pulmonary disease, renal or liver dysfunction;
5) The screening ECG and laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant;
6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Exclusion Criteria

1) History of a clinically significant allergy or anaphylaxis;
2) Patients who previously underwent a kidney transplantation;
3) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
4) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy endpoint: Signal-to-background ratio, defined as fluorescence signal<br /><br>in the kidney and ureter compared to fluorescence signal of the surrounding<br /><br>tissue. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability endpoint: The occurrence or absence of adverse events<br /><br>following administration of ZW800-1 in patients.<br /><br>Pharmacokinetic endpoint: Analysis of blood and urine samples for serum<br /><br>biochemistry, hematology and pharmacokinetics.</p><br>