UrolithiasisNERFANCT06651294
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
A study testing Neorenal Forte in people with Urolithiasis, run by Neopharm Bulgaria Ltd. at 7 sites in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Neorenal Forte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 7 sitesBulgaria
- Study dates
- 1 Apr 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 10x10x10 mm to 15x10x10 mm.
- Stone density 1001 - 1400 Hounsfield units (HU).
- Subjects post fURS for laser lithotripsy of kidney stone.
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- 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.
Who cannot join
- 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.
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- 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.
- BMI ≥ 30 kg/m2.
- Women who are pregnant or lactating; women who plan on getting pregnant during the study.
- Alcohol or drug abuse in the last year.
- Unstable medical conditions, as determined by the Investigator.
- Inability to comply with the study protocol.
- Subjects who cannot understand or not capable of completing the study documents.
- Inability to give informed consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Bulgaria7 sites
MHAT "Heart and Brain"
Burgas
UMHAT "Dr. Georgi Stranski"
Pleven, 5800
UMHAT Kaspela
Plovdiv, 4001
UMHAT "Alexandrovska"
Sofia, 1431
Military Medical Academy
Sofia, 1606
UMBALSM "N. I. Pirogov"
Sofia, 1606
UMHAT "Sofiamed"
Sofia, 1797
About this study
Official title: Efficacy and Safety of Neorenal Forte as Adjuvant Treatment for the Complete Elimination of Residual Fragments After Flexible Ureterorenoscopy With Laser Lithotripsy for Renal Calculi.
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.
Read the detailed description
The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications.
By evaluating the percentage of complete elimination of residual fragments or fragments < 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.
- Conditions
- Urolithiasis
- Being tested
- Neorenal Forte, Placebo
- Keywords
- Elimination of residual fragments, Flexible ureterorenoscopy, Renal calculi, Phytotherapeutic extracts
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neorenal ForteDietary 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).
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days + 5 days after endourological treatment.
Secondary outcomes (5)
Percentage, size and location of residual fragments.
The outcome will be categorized by radiologist via NCCT in 2 categories: ≤ 2mm, or > 2mm.
Measured: 90 days + 5 days after endourological treatment.
Number of subjects with complications associated with residual fragments or their elimination
Febrility, renal colic, protracted hematuria, hydronephrosis grade I, II, III, IV.
Measured: at 30 days and 90 days + 5 days after endourological treatment.
Percentage of subjects receiving analgesics
Administration of antipyretics as reported on the patient diary - YES/NO
Measured: Up to 90 days after endourological treatment.
Duration of analgesics administration
Administration of antipyretics as reported on the patient diary - YES/NO
Measured: Up to 90 days after endourological treatment.
Severity of pain
Clinical assessment of pain is based on visual analogue scale (VAS) from 0 to 10
Measured: Up to 90 days after endourological treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Apr 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neopharm Bulgaria Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marin Georgiev, Prof, PhD, Principal investigator, UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical UniversityIliya Saltirov, Prof, MD, PhD, DSc, Principal investigator, Military Medical Academy, Head of Department of Urology and NephrologyStanislav Valkanov, PhD, Principal investigator, UMHAT "Kaspela", Department of UrologyDeyan Anakievski, Prof, PhD, Principal investigator, MHAT "Heart and Brain", Head of Department of UrologyKaloqn Davidov, Prof, PhD, Principal investigator, UMHAT "Sofiamed", Head of Department of UrologyBoris Mladenov, PhD, Principal investigator, UMBALSM "N. I. Pirogov"Nikolay Kolev, Prof, PhD, Principal investigator, UMHAT "Dr. Georgi Stranski", Head of Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651294
- Sponsor's protocol ID
- NERFA 2501-lit-002
- Acronym
- NERFA
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neorenal Forte as Adjuvant Treatment for the Complete Elimination of Residual Fragments After Flexible Ureterorenoscopy With Laser Lithotripsy for Renal Calculi.
- ClinicalTrials.gov ID
- NCT06651294
- Acronym / sponsor ID
- NERFA / NERFA 2501-lit-002
- Conditions
- Urolithiasis
- Keywords
- Elimination of residual fragments, Flexible ureterorenoscopy, Renal calculi, Phytotherapeutic extracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Neopharm Bulgaria Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications.
By evaluating the percentage of complete elimination of residual fragments or fragments < 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
| Arm | Type | Receives |
|---|---|---|
| Neorenal Forte | Experimental | Dietary Supplement: Neorenal ForteUp 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboUp 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 10x10x10 mm to 15x10x10 mm.
- Stone density 1001 - 1400 Hounsfield units (HU).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neorenal ForteThis 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). | Dietary supplement | Neorenal Forte |
| PlaceboThe 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. | Dietary supplement | Placebo |
Primary outcome
Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.
Time frame: 90 days + 5 days after endourological treatment.
Percentage of subjects without stones or with fragments ≤ 2mm in diameter 3 months after fURS for laser lithotripsy of kidney stones, assessed by NCCT.
5 secondary outcomes
Percentage, size and location of residual fragments.
Time frame: 90 days + 5 days after endourological treatment.
Number of subjects with complications associated with residual fragments or their elimination
Time frame: at 30 days and 90 days + 5 days after endourological treatment.
Percentage of subjects receiving analgesics
Time frame: Up to 90 days after endourological treatment.
Duration of analgesics administration
Time frame: Up to 90 days after endourological treatment.
Severity of pain
Time frame: Up to 90 days after endourological treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marin Georgiev, Prof, PhD principal investigator
UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University
Iliya Saltirov, Prof, MD, PhD, DSc principal investigator
Military Medical Academy, Head of Department of Urology and Nephrology
Stanislav Valkanov, PhD principal investigator
UMHAT "Kaspela", Department of Urology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neorenal Forte in people with Urolithiasis, run by Neopharm Bulgaria Ltd. at 7 sites in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter. (time frame: 90 days + 5 days after endourological treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.