Litholytic Therapy for Coral Urate Nephrolithiasis

NCT07162974 | Completed DMC

• 1 other identifier: MSUMD Moscow
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Kidney function

  1 month

• Assessing the composition of stones

  6 months

Study Arms (1)

Citrate therapy for coralloid nephrolithiasis

EXPERIMENTAL

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

Interventions

anhydrous citric acid - 1197.0 mg, potassium bicarbonate - 967.5 mg, sodium citrate anhydrous - 835.5 mg DRUG

The dosage was selected individually for each patient, the target pH was considered to be 7.2

Citrate therapy for coralloid nephrolithiasis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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;

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Moscow State University of Medicine and Dentistry: lead

Study Sites (1)

Moscow state university of medicine and dentistry named after A.I. Evdokimov

Moscow, 127473, Russia

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Citric Acid; potassium bicarbonate; Sodium Citrate

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 49 patients with coral urate stones.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 9, 2025
• Study Start: January 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: January 9, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

RU (1)