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

November 22, 2022 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label
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
Drug: Ure-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

January 15, 2024

Study Completion (Anticipated)

June 15, 2024

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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