Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

NCT06651294 | Recruiting

• 1 other identifier: NERFA 2501-lit-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the efficacy of a specialized formula of phytotherapeutic extracts (Neorenal Forte) aiding the complete elimination of residual fragments after fURS in adults.

Conditions

Urolithiasis

Keywords

Elimination of residual fragments; Flexible ureterorenoscopy; Renal calculi; Phytotherapeutic extracts

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.

  Percentage of subjects without stones or with fragments ≤ 2mm in diameter 3 months after fURS for laser lithotripsy of kidney stones, assessed by NCCT.

  90 days + 5 days after endourological treatment.

Secondary Outcomes (5)

• Percentage, size and location of residual fragments.

  90 days + 5 days after endourological treatment.

• Number of subjects with complications associated with residual fragments or their elimination

  at 30 days and 90 days + 5 days after endourological treatment.

• Percentage of subjects receiving analgesics

  Up to 90 days after endourological treatment.

• Duration of analgesics administration

  Up to 90 days after endourological treatment.

• Severity of pain

  Up to 90 days after endourological treatment.

Study Arms (2)

Neorenal Forte

EXPERIMENTAL

Up to Day 10 after the endourological procedure - 2 tablets 2 times daily Followed by 80 days after end date of 2X2 dose - 1 tablet 2 times daily

Dietary Supplement: Neorenal Forte

Placebo

PLACEBO COMPARATOR

Up to Day 10 after the endourological procedure - 2 tablets 2 times daily Followed by 80 days after end date of 2X2 dose - 1 tablet 2 times daily

Dietary Supplement: Placebo

Interventions

Neorenal Forte DIETARY_SUPPLEMENT

This specialized formulation of phytotherapeutic extracts consists of proprietary Betula pendula leaves dry extract, Herniaria glabra, Viburnum opulus, Elymus (Agropiren) repens. The product contains supplementary ingredients: microcrystalline cellulose, povidone, magnesium stearate, colorant film (brilliant blue FCF, iron dioxide).

Neorenal Forte

Placebo DIETARY_SUPPLEMENT

The placebo product will be identical to the active form and will have the same composition but without the proprietary extract from Betula pendula, Herniaria glabra, Viburnum opulus, Elymus (Agropiren) repens.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 to 65 years of age.
• The subject has signed informed consent approved by an Ethics Committee and agrees to the on-site study visits.
• A stone confirmed by NCCT of kidney, ureter and urinary bladder for assessment of size, number, location and stone density, within 90 days of fURS.
• Single or multiple kidney stones with total size of 10x10 mm to 15x10 mm.
• Stone density 1001 - 1400 Hounsfield units (HU).
• Subjects post fURS for laser lithotripsy of kidney stone.
• Residual fragments \< 4 mm after fURS confirmed by ultrasound on first postoperative day.
• Subjects post one fURS.
• fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or urinary bladder, serious bleeding or other complications.
• No recent ureterorenoscopy within the last 6 months.
• Body mass index 17.0 - 29.99 kg/m2 118
• In Investigator's opinion, the subject can comply with the visit schedule and the treatment regimen and is capable of completing the study.
• The subject has a smartphone and is capable of using it.

You may not qualify if:

• Subjects with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
• Ureteral stenosis.
• History of ipsilateral renal surgery.
• Hydronephrosis.
• Permanent JJ stent.
• Any conditional or absolute contraindications for fURS.
• Combined ipsilateral stone in the ureter or contralateral stone in the upper urinary canal or a stone in the lower urinary canal, requiring simultaneous surgery.
• Subjects with positive urine culture, until resolution.
• History of endourological intervention (e.g. nephrostoma, ureteral catheter) before fURS.
• Stone density \<1000 and \>1401 HU;
• Uncontrolled diabetes mellitus (HbA1c \>9%).
• Renal insufficiency.
• Subjects with arterial hypertension.
• Subjects with prostate adenoma.
• Allergy or hypersensitivity to any of the ingredients of the investigational product.

Sponsors & Collaborators

• Neopharm Bulgaria Ltd.: lead

Study Sites (9)

MHAT "Heart and Brain"

Burgas, Bulgaria

RECRUITING

UMHAT "Dr. Georgi Stranski"

Pleven, 5800, Bulgaria

RECRUITING

University Hospital for Active Treatment "Saint Marina"

Pleven, 5800, Bulgaria

RECRUITING

UMHAT "St. George"

Plovdiv, 4000, Bulgaria

RECRUITING

UMHAT Kaspela

Plovdiv, 4001, Bulgaria

RECRUITING

UMHAT "Alexandrovska"

Sofia, 1431, Bulgaria

RECRUITING

Military Medical Academy

Sofia, 1606, Bulgaria

RECRUITING

UMBALSM "N. I. Pirogov"

Sofia, 1606, Bulgaria

RECRUITING

UMHAT "Sofiamed"

Sofia, 1797, Bulgaria

RECRUITING

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Marin Georgiev, Prof, PhD

  UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University

  PRINCIPAL INVESTIGATOR

• Iliya Saltirov, Prof, MD, PhD, DSc

  Military Medical Academy, Head of Department of Urology and Nephrology

  PRINCIPAL INVESTIGATOR

• Boyan Atanasov, Prof, PhD

  UMHAT "Saint Marina", Head of Department of Urology, Medical University of Pleven

  PRINCIPAL INVESTIGATOR

• Madjid Kadim, Prof, PhD

  UMHAT "St. George", Head of Department of Urology

  PRINCIPAL INVESTIGATOR

• Stanislav Valkanov, PhD

  UMHAT "Kaspela", Department of Urology

  PRINCIPAL INVESTIGATOR

• Deyan Anakievski, Prof, PhD

  MHAT "Heart and Brain", Head of Department of Urology

  PRINCIPAL INVESTIGATOR

• Kaloqn Davidov, Prof, PhD

  UMHAT "Sofiamed", Head of Department of Urology

  PRINCIPAL INVESTIGATOR

• Boris Mladenov, PhD

  UMBALSM "N. I. Pirogov"

  PRINCIPAL INVESTIGATOR

• Nikolay Kolev, Prof, PhD

  UMHAT "Dr. Georgi Stranski", Head of Department of Urology

  PRINCIPAL INVESTIGATOR

• Tosho Ganev, PhD

  MHAT "St. Anna - Varna",Head of Department of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarita Futekova

CONTACT

+359 888 151 579; m.futekova@neopharm.bg

Stefan Tunev, PhD

CONTACT

+359 888 786 540; s.tunev@neopharm.bg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators will be provided with coded products which are identical in appearance. Each individual involved in the study will be blinded to the treatment assignment until study completion. Considering the established safety profile of the formula of phytotherapeutic extracts, emergency unblinding of treatment assignment will not be necessary. So no copies of the treatment assignments will be stored at the enrollment sites. No information about the subjects will be shared with the company conducting the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-10

Locations

BU (9)