This phase 2 trial aims to assess whether daily supplementation with lipoic acid affects cystine kidney stone recurrence. The main outcome to be investigated is the recurrence rate of cystine kidney stones. The trial is recruiting in San Francisco (California), USA.
The details
Cystine stones are caused by a rare disorder called cystinuria. The disorder causes an amino acid called cystine to leak into the urine. Too much cystine in the urine can produce crystals and result in the formation of stones in the kidneys, bladder, or anywhere in the urinary tract. Lipoic acid is an of over-the-counter supplement that may have stone prevention benefits.
This study will examine whether daily supplementation with lipoic acid reduces the risk of future cystine kidney stones compared to placebo (a control drug with no active effect). The recurrence rate of cystine kidney stones will be recorded. Recurrences may be symptomatic (require treatment) or silent (imaging tests show stone growth or new stone formation).
Who are they looking for?
This study will recruit about 50 patients with a history of previous cystine kidney stones or with documented cystinuria. Participants must have a life expectancy of at least 5 years. Participants must not currently be using lipoic acid supplementation. Participants should not have uncontrolled diabetes, be currently pregnant or trying to become pregnant.
How will it work
Participants will be randomly assigned to be treated with either lipoic acid or placebo. 1200 mg of lipoic acid will be administered orally once daily for 3 years. Clinical data of all participants will be collected at visits every 4 months, including medical history, x-rays of the kidney, ureter and bladder, ultrasound of the kidney, routine blood tests and 24-hour urine collections. At the end of the 3 years, all participants will undergo a CT scan to look for a silent change in stone size. The recurrence rate of cystine kidney stones will be compared between treatment groups.
