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

Kidney Stone Clinical Trial

— Ure-Na  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04727606
• Other study ID #: 20.259
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Berl T. Impact of solute intake on urine flow and water excretion. J Am Soc Nephrol. 2008 Jun;19(6):1076-8. doi: 10.1681/ASN.2007091042. Epub 2008 Mar 12. — View Citation

Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol. 1996 Mar;155(3):839-43. — View Citation

Decaux G, Brimioulle S, Genette F, Mockel J. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by urea. Am J Med. 1980 Jul;69(1):99-106. — View Citation

Dion M, Ankawi G, Chew B, Paterson R, Sultan N, Hoddinott P, Razvi H. CUA guideline on the evaluation and medical management of the kidney stone patient - 2016 update. Can Urol Assoc J. 2016 Nov-Dec;10(11-12):E347-E358. doi: 10.5489/cuaj.4218. Epub 2016 Nov 10. — View Citation

Nayan M, Elkoushy MA, Andonian S. Variations between two 24-hour urine collections in patients presenting to a tertiary stone clinic. Can Urol Assoc J. 2012 Feb;6(1):30-3. doi: 10.5489/cuaj.11131. — View Citation

Soupart A, Coffernils M, Couturier B, Gankam-Kengne F, Decaux G. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADH. Clin J Am Soc Nephrol. 2012 May;7(5):742-7. doi: 10.2215/CJN.06990711. Epub 2012 Mar 8. — View Citation

Verbalis JG, Baldwin EF, Neish PN, Robinson AG. Effect of protein intake and urea on sodium excretion during inappropriate antidiuresis in rats. Metabolism. 1988 Jan;37(1):46-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in urine output at 1 week and 1 Month	variation in 24-hour diuresis and urine biochemistry	1 week and 1 month