Phase 4Completed
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
- Sponsor
- Advanced Accelerator Applications (Industry)
- Enrollment
- 42 enrolled
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumors
- Interventions
- arginine/lysine
- Ages
- adults, older adults
- Registry
- NCT04524442, EUCTR2019-004073-76
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Mean Change From Baseline in Serum Potassium Levels Over 24 Hours
History
Results first posted
Last registry update
Primary completion
Started
Registered