Status:
WITHDRAWN
Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Kidney Stone
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 investigat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04727606
Start Date
January 15 2023
End Date
June 15 2024
Last Update
November 28 2022
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4