E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
LysaKare® is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177 Lu) oxodotreotide in adults. |
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E.1.1.1 | Medical condition in easily understood language |
LysaKare® is indicated for kidney protection during cancer treatment with lutetium (177 Lu) oxodotreotide in adults. |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038428 |
E.1.2 | Term | Renal disorder |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029140 |
E.1.2 | Term | Nephritis radiation |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of LysaKare® administration on serum potassium concentrations in GEP-NET patients eligible for Lutathera® treatment |
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E.2.2 | Secondary objectives of the trial |
To confirm the safety profile of LysaKare® infusion in GEP-NET patients eligible for Lutathera® treatment, without co-administration of Lutathera® |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 < 50 mL/min calculated by the Cockroft Gault method; c. Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL), platelets < 75 G/L (75x103/mm3), or leucocytes < 2 G/L (2,000/mm3) (except lymphopenia); d. Liver impairment with either total bilirubinemia > 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®. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in serum potassium levels at specified time points after LysaKare® IV administration compared to baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
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E.5.2 | Secondary end point(s) |
- Incidence of LysaKare® related adverse events - Changes in vital signs and ECG parameters - Change in laboratory parameters |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial occurs after the 48 h follow-up call of the last patient treated. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |