Skip to main content

Table 3 Criteria for withdrawal / discontinuation of participants

From: Efficacy of standard and low dose hydrochlorothiazide in the recurrence prevention of calcium nephrolithiasis (NOSTONE trial): protocol for a randomized double-blind placebo-controlled trial

Discontinuation of study investigational medicinal product
 Study IMP must be permanently discontinued if any of the following occurs:
  - If any exclusion criterion applies during the trial, except the incompatible medications. The IMP will be discontinued only if the patient took the medications listed in the exclusion criteria for more than 4 months
  - If the responsible study investigator feels that treatment with the study regimen is harmful to the participant’s well-being
  - If patient is non-compliant with the study intervention as judged by the investigator and/or the sponsor
  - Pregnancy in a study participant
  - Hypokalemia (blood potassium level < 3 mmol/L) not responsive to supplementation therapy
  - Profound hyponatremia (blood sodium level < 125 mmol/L) recurring after temporary suspension of IMP
  - CKD-EPI eGFR < 30 mL/min per 1,73 m2 body surface area for more than 3 months
  - Gouty arthritis recurring > 3 times per year or requiring uric acid lowering therapy
  - Allergic reaction of skin as judged by the investigator
  - > 3 recurrences of symptomatic stone events during the trial
Discontinuation of study
 Study participants must be withdrawn from the study if the following occurs:
  - At the participants own request
  - If, in the investigator’s opinion, continuation of the study would be harmful to the subject’s wellbeing