LysaKare® is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177 Lu) oxodotreotide in adults. MedDRA version: 20.0 Level: PT Classification code 10038428 Term: Renal disorder System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: PT Classification code 10029140 Term: Nephritis radiation System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: LysaKare
Product Name: LysaKare 25g / 25g solution for infusion
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Arginine
Other descriptive name: L-ARGININE HYDROCHLORIDE
Co
Sponsors
Advanced Accelerator Applications International SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for the treatment with Lutathera® as per Lutathera® label indication. 2. Age =18 years. 3. Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related procedures. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Pre-existing hyperkalemia (>6.0 mmol/L at screening) if not adequately corrected before starting the LysaKare® infusion. 2. Instances when Lutathera® is not recommended per the Lutathera® SmPC: a. Uncontrolled congestive heart failure (NYHA III, IV); b. Kidney failure with creatinine clearance 3 times the upper limit of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%. 3. Pregnancy or lactation, positive pregnancy test at screening or pre-dose based on the contraindication for Lutathera®. 4. Hypersensitivity to the IMP active substances. 5. Any significant medical or social condition which may interfere with the subject’s ability to comply with the study visit schedule or the study assessments. 6. Patients who have received any investigational agent within the last 30 days. 7. Patients that have received a dose of Lutathera® prior to the screening visit or are scheduled for Peptide Receptor Repeat (PRRT) treatment within 7 days of the study infusion of LysaKare®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of LysaKare® administration on serum potassium concentrations in GEP-NET patients eligible for Lutathera® treatment;Secondary Objective: To confirm the safety profile of LysaKare® infusion in GEP-NET patients eligible for Lutathera® treatment, without co-administration of Lutathera®;Primary end point(s): Change in serum potassium levels at specified time points after LysaKare® IV administration compared to baseline.;Timepoint(s) of evaluation of this end point: 2 h, 4 h, 6 h, 8 h, 12 h, 24 h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of LysaKare® related adverse events - Changes in vital signs and ECG parameters - Change in laboratory parameters;Timepoint(s) of evaluation of this end point: 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h | — |
Countries
Italy, Netherlands, Poland
Contacts
Public ContactClinical Operations
Advanced Accelerator Applications International SA
Outcome results
None listed