Litholytic Therapy for Coral Urate Nephrolithiasis

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Drug: anhydrous citric acid - 1197.0 mg, potassium bicarbonate - 967.5 mg, sodium citrate anhydrous - 835.5 mg

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 127473
    • Moscow state university of medicine and dentistry named after A.I. Evdokimov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• Coral-shaped calculus, which fills one or more calyx and pelvis (K2-K4 according to the classification of coral-shaped concretions);
• The urate composition of the kidney stone was confirmed using dual-energy MSCT;
• Unimpaired or restored (by draining the kidney) urine outflow from the kidney;
• Persistently acidic urine pH (pH 5.8 or less);
• Stone density is 550 Hounsfield units or less;
• Informed voluntary consent of the patient to participate in the study;
• Patient's readiness for conservative treatment;
• No contraindications to therapy with citrate mixtures;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citrate therapy for coralloid nephrolithiasis; Patients were treated with the citrate mixture "Blemaren"	Drug: anhydrous citric acid - 1197.0 mg, potassium bicarbonate - 967.5 mg, sodium citrate anhydrous - 835.5 mg; The dosage was selected individually for each patient, the target pH was considered to be 7.2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the size, volume and density of stones.	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney function	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	1 month
Assessing the composition of stones	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.	6 months

Collaborators and Investigators

• Sponsor: Moscow State University of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): January 9, 2025

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Estimated): September 9, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Organic Chemicals; Acids, Acyclic; Carboxylic Acids; Citrates; Tricarboxylic Acids; Sodium Citrate; Citric Acid; potassium bicarbonate
• Other Study ID Numbers: MSUMD Moscow

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No