Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
Phase 2
Withdrawn
- Conditions
- Kidney Stone
- Interventions
- Drug: Ure-Na
- Registration Number
- NCT04727606
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief Summary
In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence.
The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 18 to 60 years of age
- High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.)
- Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months)
Exclusion Criteria
- Patient does not meet 1 of the 3 inclusion criteria
- Pregnancy or breastfeeding
- Lack of understanding about the protocol and effects of Ure-Na
- Expected inability to adequately increase fluid intake on Ure-Na
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open label Ure-Na The study provides for a single group, which will be its own control (pre/post intervention study). Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) for 1 month
- Primary Outcome Measures
Name Time Method Change From Baseline in urine output at 1 week and 1 Month 1 week and 1 month variation in 24-hour diuresis and urine biochemistry
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada