Patients undergoing a living-donor kidney transplantation (living kidney donor and kidney recipient)
Conditions
Interventions
Product Name: ZW800-1
Product Code: ZW800-1
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The occurrence or absence of adverse events following administration of ZW800-1 in patients. - Analysis of blood and urine samples for serum biochemistry, hematology and pharmacokinetics. ;Timepoint(s) of evaluation of this end point: Follow-up | — |
Countries
Netherlands
Contacts
Public ContactKim de Valk
Leiden University Medical Center
Outcome results
None listed