Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence (Ure-Na)

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Withdrawn; Phase 2

Conditions: Kidney Stone

Treatments: Drug: Ure-Na

Study type: Interventional

Funder types: Other

Identifiers

NCT04727606

20.259

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Open label

Experimental group

Description:

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

Treatment:

Drug: Ure-Na