Litholytic Therapy for Coral Urate Nephrolithiasis

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Drug: anhydrous citric acid - 1197.0 mg, potassium bicarbonate - 967.5 mg, sodium citrate anhydrous - 835.5 mg

• Registration Number: NCT07162974
• Lead Sponsor: Moscow State University of Medicine and Dentistry

Brief Summary

This is a prospective cohort study, patients with coralloid nephrolithiasis. Purpose of the study: to evaluate the efficacy and safety of litholytic therapy of coral-like urate nephrolithiasis with citrate mixtures.

Detailed Description

Anthropometric parameters height and weight were recorded in all patients, body mass index was calculated. All patients underwent MSCT of the urinary tract to assess the volume of density and concrements before the start of therapy. Biochemical blood analysis included determination of creatinine level with subsequent calculation of SCF. Urine pH was monitored for 72 hours using an electronic pH meter before therapy and recorded in a diary by patients three times a day, after which the average pH was calculated. Patients who met the inclusion criteria were included in the study after signing informed consent.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-10-30
• Study Completion: 2025-01-09
• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Citrate therapy for coralloid nephrolithiasis	anhydrous citric acid - 1197.0 mg, potassium bicarbonate - 967.5 mg, sodium citrate anhydrous - 835.5 mg	Patients were treated with the citrate mixture "Blemaren"

Primary Outcome Measures

Name	Time	Method
Assessment of the size, volume and density of stones.	1 month	Computer tomography is the "gold standard" for diagnosing urolithiasis; it will allow you to identify stones, determine their size, density, structure, location, and assess the condition of the urinary tract.

Secondary Outcome Measures

Name	Time	Method
Kidney function	1 month	Glomerular filtration rate (GFR, ml/min/1.73 m2) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the glomeruli each minute. A GFR of 60 or higher is in the normal range. A GFR below 60 may mean kidney disease. A GFR of 15 or lower may mean kidney failure.; The measurement of the glomerular filtration rate will be measured according to the results of the blood test
Assessing the composition of stones	6 months	Chemical analysis of stones is a spectrometric (infrared spectroscopy) method that determines its exact composition by analyzing how the stone absorbs infrared radiation. Chemical analysis of stones will be performed on those patients who will undergo surgical treatment.

Trial Locations

Locations (1)

Moscow state university of medicine and dentistry named after A.I. Evdokimov; 🇷🇺 Moscow, Russia