---
title: "Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence"
nct_id: NCT04727606
overall_status: WITHDRAWN
phase: PHASE2
sponsor: "Centre hospitalier de l'Université de Montréal (CHUM)"
study_type: INTERVENTIONAL
primary_condition: Kidney Stone
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04727606.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04727606"
ct_last_update_post_date: 2022-11-28
last_seen_at: "2026-05-12T07:28:02.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

**NCT ID:** [NCT04727606](https://clinicaltrials.gov/study/NCT04727606)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** We never got Health Canada approval
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Centre hospitalier de l'Université de Montréal (CHUM)
- **Conditions:** Kidney Stone
- **Start Date:** 2023-01-15
- **Completion Date:** 2024-06-15
- **CT.gov Last Update:** 2022-11-28

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **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
```

## Arms

- **Open label** (EXPERIMENTAL) — 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

## Interventions

- **Ure-Na** (DRUG) — * 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.

## Primary Outcomes

- **Change From Baseline in urine output at 1 week and 1 Month** _(time frame: 1 week and 1 month)_ — variation in 24-hour diuresis and urine biochemistry

## Locations (1)

- Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier de l'université de montréal (chum)|montreal|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04727606.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04727606*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*