Litholytic Therapy for Coral Urate Nephrolithiasis

NCT ID: NCT07162974

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-01-09

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.

Conditions

Urolithiasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Citrate therapy for coralloid nephrolithiasis

Patients were treated with the citrate mixture "Blemaren"

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

MSUMD Moscow

Identifier Type: -

Identifier Source: org_study_id