At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 42 enrolled
Drug / intervention
arginine/lysinedrug
Likely dose
arginine/lysine 250 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating arginine/lysine for Gastroenteropancreatic Neuroendocrine Tumors. Completed, enrolled 42 participants across 7 sites in 4 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, Netherlands, Poland, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartJan 2021
Primary CompletionNov 2023
TodayJul 2026
First PostedAug 24, 2020
Enrollment StartJan 25, 2021
Primary CompletionNov 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.9 years ago
Interventions
arginine/lysinedrug
1000 milliliters (mL) administered at a constant rate of 250 mL per hour