ZW800-1 in kidney transplantations

Phase 1

• Conditions: Patients undergoing a living-donor kidney transplantation (living kidney donor and kidney recipient); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-000985-12-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• 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.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the feasibility of ZW800-1 in the intraoperative assessment of kidney and ureter perfusion during kidney transplantations (living donor nephrectomy and transplantation);Secondary Objective: To determine the concordance between fluorescence signal and kidney function (ZW800-1 clearance in urine);Primary end point(s): Signal-to-background ratio, defined as fluorescence signal in the kidney and ureter compared to fluorescence signal of the surrounding tissue. ;Timepoint(s) of evaluation of this end point: During surgery

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - The occurrence or absence of adverse events following administration of ZW800-1 in patients. <br> - Analysis of blood and urine samples for serum biochemistry, hematology and pharmacokinetics.<br> ;Timepoint(s) of evaluation of this end point: Follow-up