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Potassium citrate is a salt of citric acid. In the clinical trial record provided, it appears within the list of interventions for a study of [177Lu]Lu-DOTA-TATE, a radiolabelled medicine used in neuroendocrine tumours.[1] The substance data describe the therapeutic area as neoplasms, which fits the condition studied in the trial.[1]
Potassium citrate is a chemical substance used in various oral forms, including oral solutions, modified-release tablets, capsules, granules and effervescent tablets.[2] It is used to make urine less acidic (urine alkalinisation) and is listed in NHS formularies for urological pain, cystitis and cystinuria.[5][3] In the trial record for GEP-NET, potassium citrate is listed among the interventions but is not the substance whose efficacy the trial is designed to test.[1]
Potassium citrate works by making the urine less acidic. It is grouped under drugs used in urological pain and urine alkalinisation in the NHS formulary chapters.[5][3] One formulary describes a mixture containing potassium citrate 300 mg per 1 ml with citric acid monohydrate 50 mg per 1 ml for urological pain.[4] The trial record itself does not describe a mechanism of action for potassium citrate.[1]
Potassium citrate is available as oral solutions, modified-release tablets, capsules, granules for oral solution and effervescent tablets.[2] The dm+d browser lists many of these forms, including potassium citrate 1.08 g modified-release tablets, 3 g granules for oral solution sachets and 2.27 g/5 ml oral solution.[2] In the GEP-NET trial record, potassium citrate is listed with no dosage form stated.[1]
There is one trial in the data, a phase 3 interventional study with 241 participants (EU CT number 2024-518325-15-00).[1] Its status is authorised, meaning it has received approval but results are not yet reported.[1] The trial is designed to show whether [177Lu]Lu-DOTA-TATE plus octreotide LAR is superior to an active comparator in delaying progression or death as first-line treatment for grade 1 and grade 2 advanced GEP-NET.[1] The primary outcome is progression-free survival (PFS), defined as the time from randomisation to the first occurrence of centrally assessed progression according to RECIST v1.1 or death from any cause.[1] The interventions include Sandostatin LAR (octreotide LAR) at 10 mg, 20 mg and 30 mg given by intramuscular injection, Lutathera ([177Lu]Lu-DOTA-TATE) 370 MBq/mL solution for infusion given intravenously, LysaKare 25 g/25 g solution for infusion, metoclopramide and octreotide given subcutaneously.[1] Potassium citrate is listed among these interventions but the record does not state its role or dose.[1]
The supplementary sources provided do not describe side effects for potassium citrate. The trial record does not report side effects either.[1]
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