Last Update: May 25, 2023
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 Identifier:
Novartis Reference Number:CAAA001A12401
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of the study is to evaluate the effect of arginine/lysine solution administration on serum potassium levels. A systematic assessment of serum potassium levels will be performed during infusion and up to 24 hours post start of infusion compared to baseline.

Gastroenteropancreatic Neuroendocrine Tumors
Phase 4
Jan 27, 2021
Sep 29, 2023
18 Years - (Adult, Older Adult)




1000 milliliters (mL) administered at a constant rate of 250 mL per hour

Eligibility Criteria

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 arginine/lysine solution infusion (applicable to all countries except Poland).
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.

Study Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)


Meldola,Contact: Stefano Severi, Dr,47014 - FC,Italy

Istituto Europero di Oncologia


Milan,Contact: Chiara Grana, Dr,20141 - MI,Italy

Erasmus University Medical Center


Rotterdam,Contact: Hans Hofland, Dr,3015 - GD,Netherlands

Gammed-Centrum Diagnostyczno-Lecznicze



Liverpool Royal Hospital


Liverpool,L7 8YA,United Kingdom

Royal Surrey County Hospital


Guildford,GU2 7XX,United Kingdom

University Hospitals Birmingham NHS Foundation Trust


Birmingham,B15 2GW,United Kingdom

University Hospitals Coventry & Warwickshire NHS Trust


Coventry,CV2 2DX,United Kingdom

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