Clinical trial · Interventional
Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
A Multicenter, Open-label Post Authorization Safety Study to Evaluate the Effect of LysaKare® Infusion on Serum Potassium Levels in GEP-NET Patients Eligible for Lutathera® Treatment
NCT04524442CI-TRIAL-00085064completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study was to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels was performed during infusion and up to 24 hours post start of infusion compared to baseline.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumors | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arginine/lysine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GEP-NET
- description
- One dose of arginine/lysine solution administered intravenously over a 4-hour period
- interventionNames
- Drug: arginine/lysine
Primary outcomes (1)
- measure
- Mean Change From Baseline in Serum Potassium Levels Over 24 Hours
- timeFrame
- Day 0/Infusion Day (Hour 0, Hour 2, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24)
- description
- Serum potassium levels at each collection time point will be measured at local laboratories of study sites using validated methods. The potassium concentration results will be summarized descriptively and will include mean change, maximum change, time to the maximum change, and the overall dynamics of the potassium concentration curve during and after the arginine/lysine infusion.
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for the treatment with Lutathera as per Lutathera label indication. * Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related procedures. Exclusion Criteria: * Pre-existing hyperkalemia (\>6.0 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion. For Poland only, pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the LysaKare (arginine/lysine) infusion. * Instances when Lutathera is not recommended per the Lutathera Summary of Product Characteristics (SmPC). * Pregnancy or lactation, positive pregnancy test at screening or pre-dose based on the contraindication for Lutathera. * 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. * Patients who have received any investigational agent within the last 30 days. * 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 arginine/lysine solution. * Other protocol-defined exclusion criteria may apply. Exclusion Criteria (Poland Only): \- Pre-existing hyperkalemia (\> 5.5 mmol/L at screening) if not adequately corrected before starting the arginine/lysine solution infusion.
References
Publications (0)
Data not yet available
No reference posted for this study.