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Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04727606
Acronym
Ure-Na
Enrollment
0
Registered
2021-01-27
Start date
2023-01-15
Completion date
2024-06-15
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone

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.

Interventions

DRUGUre-Na

* 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) * Treatment will continue for approximately 1 month.

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in urine output at 1 week and 1 Month1 week and 1 monthvariation in 24-hour diuresis and urine biochemistry

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026