Genetic Study of Nephrolithiasis in Gouty Diathesis (NCT00149305) | Clinical Trial Compass
TerminatedNot Applicable
Genetic Study of Nephrolithiasis in Gouty Diathesis
Stopped: Non significative preliminary data
Italy37 participantsStarted 2005-05
Plain-language summary
Gouty diathesis describes uric acid or calcium oxalate nephrolithiasis and low urinary pH (\<5.5). A hereditary component has been outlined for several forms of nephrolithiasis (such as hypercalciuria, hyperoxaluria, cystinuria, renal tubular acidosis), leading to the hypothesis of a genetic predisposition to nephrolithiasis. At the Unit of Nephrology, Ospedali Riuniti di Bergamo, more than 100 patients affected by gouty diathesis are followed. Fifty percent of them has a familiarity for kidney stones formation. The aim of our study is to identify the genetic factors that predispose to the development of nephrolithiasis in patients with gouty diathesis.
Who can participate
Age range
10 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* male and female, ≥ 10 years of age
* uric acid or calcium oxalate nephrolithiasis
* urinary 24 h pH \< 5.5 in absence of high animal protein intake (urinary sulphate excretion \<25 mM/24 h after one week of low animal protein intake)
* familial history of kidney stones (at least two first or second degree family members affected)
* written informed consent according to the Declaration of Helsinki guidelines
Exclusion Criteria:
* renal colic in the 4 weeks preceding evaluations
* excessive gastrointestinal alkali loses
* inability to fully understand the purposes of the study or to provide a written informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00149305
SponsorMario Negri Institute for Pharmacological Research