Litholytic Therapy for Coral Urate Nephrolithiasis

September 8, 2025 updated by: Moscow State University of Medicine and Dentistry
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

Intervention / Treatment

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

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

Study Locations

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

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

  • 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

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

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.
Time Frame: 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.
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Moscow State University of Medicine and Dentistry

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 (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

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

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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