Calculus of Upper Urinary Tract (Disorder)AMMOSNCT04860492
The Impact of Renalof® Dietary Supplement on Upper Urinary Tract Stone Volume
A study testing Renalof 325mg in people with Calculus of Upper Urinary Tract (Disorder), run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Following informed consent, all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of "G. Gennimatas" hospital and reported by the same dedicated uroradiologist for evaluation of stone volume, location, and consistency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calculus of Upper Urinary Tract (Disorder)
- What is being tested?
- Renalof 325mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2020to 1 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Upper urinary tract stones
- Stone density > 500 HU on CT (Mean Hounsfield Units of the largest stone)
- Ability to understand and provide a written informed consent to participate in the study
Who cannot join
- Staghorn stones occupying renal calyces and pelvis
- Stone composition other than calcium, indirectly assessed or determined using the Hounsfield stone density units (a Mean Hounsfield score of < 500 units will be considered)
- Use of other urinary urinary stone treatments
- Use of magnesium supplementation
- Chronic kidney disease (CKD) with eGFR<30 ml/sec
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Agropyron Repens, Mannitol and Magnesium Supplement for the Treatment of Calcium Oxalate Upper Urinary Tract Stones: The AMMOS Study
Following informed consent, all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of "G. Gennimatas" hospital and reported by the same dedicated uroradiologist for evaluation of stone volume, location, and consistency. All patients will also have a free flow mid-stream urinalysis and culture before randomization.
The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study.
Read more
Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire (m-USSQ) and the PUF questionnaire completed one week into study, before commencement of treatment and at the end of the study after taking either RENALOF® or placebo. Patients with a DJ stent in situ at study entry, will have both ends of the DJ cut and send for culture during scheduled DJ stent change. Approximately 90 days after recruitment, all patients will have a follow up CT scan, done at "G. Gennimatas" hospital radiology department and evaluated by the same dedicated uroradiologist , and a mid-stream urinalysis and culture. Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis. All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires.
During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events.
Read the detailed description
A total of 82 patients with renal stone or ureteral stones measured on a CT scan performed no later than 1 month prior to randomization, will be recruited in the study. Full medical history as well as demographic data and relevant medical treatment will be recorded in all eligible patients, followed by a detailed physical examination.
All eligible patients who have read and signed the study consent form will be randomized to either RENALOF® or placebo.
The randomization sequence will be computer-generated by the study coordinating team. Randomization will be performed before enrolment of the first patient.
Both the investigators and the study participants will be blinded to the treatment received (RENALOF® or placebo). Following randomization, the participants will be given prefilled non-labelled boxes containing either active drug (RENALOF®) or placebo. The pills in all boxes will be visually identical in size, weight and shape. Each box will have a tag with a unique code. A list of all dispersed coded boxes and the type of drug each box contains (RENALOF® or placebo) will be kept sealed by the study coordinator until the end of the study. Only at the end of the study period the research team will be unblinded to the treatment each patient had received.
The study will be carried out in prespecified time-points, which are listed below:
Point 0 (P0): Screening visit and randomization:
Participants will provide a written informed consent before enrolment. A full medical history will be recorded including medications, interventions for upper tract stones (ESWL, URS, PCNL), medical treatment for stones, history of spontaneous stones passage. Findings on clinical examination and patient demographic characteristics (body weight, height, body mass index (BMI) will be recorded.
The size, number and location of stones on CT scan will be recorded along with any other relevant finding (horseshoe kidney, UPJ obstruction, duplicate collecting system, ureteric stricture etc.). The location, size, surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient. All CT studies will be evaluated and stone parameters will be estimated by the same independent dedicated certified radiologist using the Invesalius computer software.
All patients will have a baseline Urea and electrolytes (U and E) blood test, free flow random sample urinalysis and culture. U and E will include serum creatinine, sodium, potassium, calcium and albumin. Parathyroid hormone will also be assessed to confirm or exclude hyperparathyroidism. Urinalysis includes pH, specific weight, sodium, calcium, oxalate, uric acid, citrate and magnesium. Urine culture tests for the possibility of a urinary tract infection (UTI) and if necessary, sensitivity will be carried out which will help treatment.
Patients with indwelling DJ stents will have their stents changed under local anesthesia. In order to reduce patient discomfort and stent related symptoms (SRS) the stent length for each patient will be estimated on the basis of individual patient's height as follows: height < 175 cm will receive a 22F stent, > 175 cm < 190 cm will receive a 24 F stent and patients taller than 190 cm will have a 26F stent. Care will be taken that the loop of the stents in the bladder does not cross the midline. The distal and proximal ends of the stent will be sent for culture. Patients with DJ stents will complete a m-USSQ and a PUF questionnaire 2 weeks following stent insertion or stent change. This will be done in order to avoid bias as patients will have this procedure done under local anesthesia.
Patients will then be randomized and 3 unlabeled boxes containing a total of 120 pills (3-month supply) of either active treatment (RENALOF®) or placebo will be dispersed. The patients will be asked to take 3 pills daily for 90 days.
Point 1 (P1): End of the 90-day RENALOF® treatment All participants will have a follow up CT scan. The location, size, surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient. The findings will be compared to those of the baseline CT scan. Estimation of all stone parameters (location, size, surface area, stone volume) will be done by the same radiologist as in the screening visit in order to avoid interobserver variability. Incidences of spontaneous stone passage will be recorded.
All patients will have a repeat free flow urinalysis and culture and complete a VAS.
Patients with DJ stents will have their stents changed and the stent ends will be sent for culture and sensitivity. Patients with stents will complete a m-USSQ and PUF questionnaire. Incidences of UTIs (with a positive urine culture) during the study period will be recorded. Treatment related adverse events and drop-out rates will be recorded.
Once final assessment of all recruited patients has been completed, researchers will be unblinded to the type of treatment each patient has received (RENALOF® or placebo). The patients will then form 2 groups (group A, n = 41, those who received RENALOF®; and group B, n = 41, those who received placebo) and the groups will be compared for primary and secondary study endpoints.
- Being tested
- Renalof 325mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renalof 325mgDietary supplement
RENALOF® is a preparation that contains active Agropyron repens extract. It is designed with specific antioxidant compounds triggered by a bio-catalyst process that enables improved control of the production mechanism of anti-stress molecules. RENALOF® contains extracts of couch grass (triticin, potassium salts, agropyron, silicic salt, inositol, vanillin, saponin, mucilage, iron, and others trace elements), mannitol, corn starch and magnesium silicate. The magnesium in RENALOF® inhibits stone formation by inhibition of growth of crystals and aggregation.
| Study group | Role | What they receive |
|---|---|---|
| Renalof | Active comparator | Patients will be given and, advised to take Renalof tablets 325mg three times a day for 90 days Receives: Dietary Supplement: Renalof 325mg |
| Placebo | Placebo comparator | Patients will be given and, advised to take Placebo three times a day for 90 days Receives: Dietary Supplement: Renalof 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone volume
Stone volume (measured in mls) will be calculated using a dedicated software
Measured: 90 days
Secondary outcomes (5)
Stent-related symptoms score in the cohort of patients with DJ stents.
Symptoms score will be assessed using the mini-Ureteral Stent Symptoms Score (m-USSS). The Mini Ureteral Stent Symptoms Questionnaire (mini-USSQ) is a validated, simplified, and shorter version of the 38 item Ureteral Stent Symptoms Questionnaire. It has 8 questions and a maximum of 77 points for women and 87 for men with maximum values showing worst symptoms.
Measured: 90 days
Overactive Bladder (OAB) Symptoms score
OAB scores will be assessed by the Pelvic Pain and Urgency-Frequency (PUF) questionnaire.The Pelvic Pain and Urgency/Frequency Patient Symptoms Scale (PUF) is an 8 question instrument used to assess pelvic symptoms. Scores range from 0 to 35 points with 35 being the worst feeling of pelvic related discomfort.
Measured: 90 days
Pain level
Pain scores will be assessed by the Visual Analogue Score (VAS).The Visual analogue score (VAS) is an tool which is used to determine pain on a level from 1 to 10 shown diagrammatically. No pain is 1 on the VAS score and excessive pain is indicated with a 10 on the scale.
Measured: 90 days
Microbial growth of double J stents in the cohort of patients with DJ stents.
the proximal and distal ends of the removed double J stents will be sent for culture
Measured: 90 days
Incidence of documented urinary tract infections
patients will be asked to report any urinary tract infections (defined as symptoms of a UTI and a positive urine culture)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Sep 2020
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculus of Upper Urinary Tract (Disorder)Studies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sountoulidis Petros, Aristotle University Of Thessaloniki
- Investigators
- Petros Sountoulides, M.D, Phd, Principal investigator, Aristotle Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860492
- Sponsor's protocol ID
- Agropyron-1
- Acronym
- AMMOS
- Status last verified
- Sep 2023
- First submitted
- 13 Apr 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Agropyron Repens, Mannitol and Magnesium Supplement for the Treatment of Calcium Oxalate Upper Urinary Tract Stones: The AMMOS Study
- ClinicalTrials.gov ID
- NCT04860492
- Acronym / sponsor ID
- AMMOS / Agropyron-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Apr 2021 (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.
Following informed consent, all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of "G. Gennimatas" hospital and reported by the same dedicated uroradiologist for evaluation of stone volume, location, and consistency. All patients will also have a free flow mid-stream urinalysis and culture before randomization.
The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study.
Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire (m-USSQ) and the PUF questionnaire completed one week into study, before commencement of treatment and at the end of the study after taking either RENALOF® or placebo. Patients with a DJ stent in situ at study entry, will have both ends of the DJ cut and send for culture during scheduled DJ stent change. Approximately 90 days after recruitment, all patients will have a follow up CT scan, done at "G. Gennimatas" hospital radiology department and evaluated by the same dedicated uroradiologist , and a mid-stream urinalysis and culture. Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis. All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires.
During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events.
Detailed description
A total of 82 patients with renal stone or ureteral stones measured on a CT scan performed no later than 1 month prior to randomization, will be recruited in the study. Full medical history as well as demographic data and relevant medical treatment will be recorded in all eligible patients, followed by a detailed physical examination.
All eligible patients who have read and signed the study consent form will be randomized to either RENALOF® or placebo.
The randomization sequence will be computer-generated by the study coordinating team. Randomization will be performed before enrolment of the first patient.
Both the investigators and the study participants will be blinded to the treatment received (RENALOF® or placebo). Following randomization, the participants will be given prefilled non-labelled boxes containing either active drug (RENALOF®) or placebo. The pills in all boxes will be visually identical in size, weight and shape. Each box will have a tag with a unique code. A list of all dispersed coded boxes and the type of drug each box contains (RENALOF® or placebo) will be kept sealed by the study coordinator until the end of the study. Only at the end of the study period the research team will be unblinded to the treatment each patient had received.
The study will be carried out in prespecified time-points, which are listed below:
Point 0 (P0): Screening visit and randomization:
Participants will provide a written informed consent before enrolment. A full medical history will be recorded including medications, interventions for upper tract stones (ESWL, URS, PCNL), medical treatment for stones, history of spontaneous stones passage. Findings on clinical examination and patient demographic characteristics (body weight, height, body mass index (BMI) will be recorded.
The size, number and location of stones on CT scan will be recorded along with any other relevant finding (horseshoe kidney, UPJ obstruction, duplicate collecting system, ureteric stricture etc.). The location, size, surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient. All CT studies will be evaluated and stone parameters will be estimated by the same independent dedicated certified radiologist using the Invesalius computer software.
All patients will have a baseline Urea and electrolytes (U and E) blood test, free flow random sample urinalysis and culture. U and E will include serum creatinine, sodium, potassium, calcium and albumin. Parathyroid hormone will also be assessed to confirm or exclude hyperparathyroidism. Urinalysis includes pH, specific weight, sodium, calcium, oxalate, uric acid, citrate and magnesium. Urine culture tests for the possibility of a urinary tract infection (UTI) and if necessary, sensitivity will be carried out which will help treatment.
Patients with indwelling DJ stents will have their stents changed under local anesthesia. In order to reduce patient discomfort and stent related symptoms (SRS) the stent length for each patient will be estimated on the basis of individual patient's height as follows: height < 175 cm will receive a 22F stent, > 175 cm < 190 cm will receive a 24 F stent and patients taller than 190 cm will have a 26F stent. Care will be taken that the loop of the stents in the bladder does not cross the midline. The distal and proximal ends of the stent will be sent for culture. Patients with DJ stents will complete a m-USSQ and a PUF questionnaire 2 weeks following stent insertion or stent change. This will be done in order to avoid bias as patients will have this procedure done under local anesthesia.
Patients will then be randomized and 3 unlabeled boxes containing a total of 120 pills (3-month supply) of either active treatment (RENALOF®) or placebo will be dispersed. The patients will be asked to take 3 pills daily for 90 days.
Point 1 (P1): End of the 90-day RENALOF® treatment All participants will have a follow up CT scan. The location, size, surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient. The findings will be compared to those of the baseline CT scan. Estimation of all stone parameters (location, size, surface area, stone volume) will be done by the same radiologist as in the screening visit in order to avoid interobserver variability. Incidences of spontaneous stone passage will be recorded.
All patients will have a repeat free flow urinalysis and culture and complete a VAS.
Patients with DJ stents will have their stents changed and the stent ends will be sent for culture and sensitivity. Patients with stents will complete a m-USSQ and PUF questionnaire. Incidences of UTIs (with a positive urine culture) during the study period will be recorded. Treatment related adverse events and drop-out rates will be recorded.
Once final assessment of all recruited patients has been completed, researchers will be unblinded to the type of treatment each patient has received (RENALOF® or placebo). The patients will then form 2 groups (group A, n = 41, those who received RENALOF®; and group B, n = 41, those who received placebo) and the groups will be compared for primary and secondary study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renalof | Active comparator | Dietary Supplement: Renalof 325mgPatients will be given and, advised to take Renalof tablets 325mg three times a day for 90 days |
| Placebo | Placebo comparator | Dietary Supplement: Renalof 325mgPatients will be given and, advised to take Placebo three times a day for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Upper urinary tract stones
- Stone density > 500 HU on CT (Mean Hounsfield Units of the largest stone)
- Ability to understand and provide a written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Staghorn stones occupying renal calyces and pelvis
- Stone composition other than calcium, indirectly assessed or determined using the Hounsfield stone density units (a Mean Hounsfield score of < 500 units will be considered)
- Use of other urinary urinary stone treatments
- Use of magnesium supplementation
- Chronic kidney disease (CKD) with eGFR<30 ml/sec
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 |
|---|---|---|
| Renalof 325mgRENALOF® is a preparation that contains active Agropyron repens extract. It is designed with specific antioxidant compounds triggered by a bio-catalyst process that enables improved control of the production mechanism of anti-stress molecules. RENALOF® contains extracts of couch grass (triticin, potassium salts, agropyron, silicic salt, inositol, vanillin, saponin, mucilage, iron, and others trace elements), mannitol, corn starch and magnesium silicate. The magnesium in RENALOF® inhibits stone formation by inhibition of growth of crystals and aggregation. | Dietary supplement | Placebo, Renalof |
Primary outcome
Stone volume
Time frame: 90 days
Stone volume (measured in mls) will be calculated using a dedicated software
5 secondary outcomes
Stent-related symptoms score in the cohort of patients with DJ stents.
Time frame: 90 days
Overactive Bladder (OAB) Symptoms score
Time frame: 90 days
Pain level
Time frame: 90 days
Microbial growth of double J stents in the cohort of patients with DJ stents.
Time frame: 90 days
Incidence of documented urinary tract infections
Time frame: 90 days
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 26 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Petros Sountoulides, M.D, Phd principal investigator
Aristotle Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renalof 325mg in people with Calculus of Upper Urinary Tract (Disorder), run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 6 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Stone volume (time frame: 90 days). 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 26 Sep 2023.