CystinuriaNCT03539926
This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).
A study testing Reactive strips in people with Cystinuria, run by Devicare S.L. at 1 site in Spain.
Trial summary
This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystinuria
- What is being tested?
- Reactive strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2018to Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- Cystinuric patients, with or without urinary lithiasis at the time of inclusion.
- Patients who accept their participation in the study and give their informed consent.
Who cannot join
- Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled and Opened Trial on the Impact of the Use of a pH-Meter on the Domiciliary Control of the Urinary pH as Adjuvant to the Treatment of Cystinuric Patients
This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care).
Read the detailed description
Cystinuria is a disease of autosomal recessive inheritance. This disease belongs to the so-called orphan diseases although its prevalence may change depending on the country.
It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.
The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.
- Conditions
- Cystinuria
- Being tested
- Lit-control®pH Meter, Reactive strips
- Keywords
- Cystinuria, pH Control
- Medical subject headings
- Cystinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lit-control®pH MeterDevice
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
Reactive stripsDiagnostic test
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
| Study group | Role | What they receive |
|---|---|---|
| Lit-control®pH Meter | Experimental | The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the Lit-control®pH Meter device. Receives: Device: Lit-control®pH Meter |
| Reactive strips | Placebo comparator | The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the reactive strips. Receives: Diagnostic Test: Reactive strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
Urinary pH measurement
Measured: 183 measurements (morning) in 6 months.
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
Urinary pH measurement
Measured: 183 measurements (afternoon) in 6 months.
Measurement of the volume of crystalluria.
volume of crystalluria
Measured: 1 measurement at the moment of enrollment
Measurement of the volume of crystalluria.
volume of crystalluria
Measured: 1 measurement at 6 months
Blood: DNA extraction.
Extraction of DNA for genetic study of mutations for cystinuria.
Measured: 1 measurement at the moment of enrollment
Sediment analysis for the determination of urinary infection.
Sediment analysis for the determination of Ulcer Index (UI)
Measured: 1 measurement at the moment of enrollment
Sediment analysis for the determination of urinary infection.
Sediment analysis for the determination of UI
Measured: 1 measurement at 6 months
Total time within the margins established as safe in the pH control (months).
Amount of time within the pH margins established as safe
Measured: 1 measurement through study completion [up to 6 months]
Adherence level in pH measurements
% compliance of the pH measurements
Measured: Through study completion, fraction of pH measurements on the total possible. [up to 6 months]
Adherence level to treatment
% of the intakes of the medication.
Measured: Through study completion, fraction of intakes on the total possible. [up to 6 months]
Total number of adverse events reported.
Amount of adverse events reported
Measured: Through study completion, number of events. [up to 6 months]
Blood Analysis. Glucose
Glucose in mmol/L
Measured: Change from Baseline measurement at 6 months
Blood Analysis. Calcium phosphate
calcium phosphate in µmol/L
Measured: Change from Baseline measurement at 6 months
Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)
estimated FG CKD-EPI
Measured: Change from Baseline measurement at 6 months
Blood Analysis. Cystatin
cystatin in mg/L (to be measured only if estimated FG> 45 or <ml /min / 1.73 m2 and albumin / creatinine in the urine <3 mg / mmol)
Measured: Change from Baseline measurement at 6 months
Blood Analysis. Creatinine
creatinine in µmol/L
Measured: Change from Baseline measurement at 6 months
Blood Analysis. Urate
urate in μmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Weight
Weight in kg
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Size
Size in m
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Urinary volume
Urinary volume in L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Calcium phosphate
calcium phosphate in µmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Citrate
citrate in μmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Urate
urate in μmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Magnesium
magnesium in μmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Sodium
sodium in μmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. BMI
weight and height will be combined to report BMI in kg/m^2
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Potassium
potassium in μmol/L
Measured: Change from Baseline measurement at 6 months
24h Urine Analysis. Urea
urea in µmol/L
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Schedule
First urine of the morning (totality) for the study of crystalluria. Patient will provide the last hour of urination and hour of urine obtention in the morning.
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Crystalline volume
overall crystalline volume (μm3 / mL)
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Crystals
type and number of crystals (crystals / μL)
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Urine volume
urine volume in L
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. pH
pH
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Size
size in μm
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Density
Density in mg / mL.
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Aggregation
aggregation
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Twinning
twinning
Measured: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Quotient
Quotient albumin / creatinine
Measured: Change from Baseline measurement at 6 months
Secondary outcomes (3)
Sociodemographic and anthropometric questionnaire.
Family and personal background and general data (sex, age, etc.).
Measured: 1 day of enrollment
Patient satisfaction questionnaire with the pH measurement method
Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)
Measured: 3 times in 6 months
Physician satisfaction questionnaire with the pH measurement method
Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied
Measured: 3 times in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start9 Apr 2018
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystinuriaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive the product for home pH monitoring, but they will keep following the doctor's recommendations indicated in the usual clinical practice. The proportion of patients will be 1: 1 between the study group (Lit-control®pH Meter) and the control group (test strips).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devicare S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L., Fundacio Puigvert
- Responsible party
- Sponsor
- Investigators
- Oriol Angerri, MD, Principal investigator, Fundacio Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539926
- Sponsor's protocol ID
- DEV-LCD-01-17
- Status last verified
- Nov 2018
- First submitted
- 23 Mar 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled and Opened Trial on the Impact of the Use of a pH-Meter on the Domiciliary Control of the Urinary pH as Adjuvant to the Treatment of Cystinuric Patients
- ClinicalTrials.gov ID
- NCT03539926
- Acronym / sponsor ID
- DEV-LCD-01-17
- Conditions
- Cystinuria
- Keywords
- Cystinuria, pH Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Devicare S.L.Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L., Fundacio Puigvert
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 30 May 2018 (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.
This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care).
Detailed description
Cystinuria is a disease of autosomal recessive inheritance. This disease belongs to the so-called orphan diseases although its prevalence may change depending on the country.
It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.
The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will receive the product for home pH monitoring, but they will keep following the doctor's recommendations indicated in the usual clinical practice. The proportion of patients will be 1: 1 between the study group (Lit-control®pH Meter) and the control group (test strips).
| Arm | Type | Receives |
|---|---|---|
| Lit-control®pH Meter | Experimental | Device: Lit-control®pH MeterThe control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the Lit-control®pH Meter device. |
| Reactive strips | Placebo comparator | Diagnostic Test: Reactive stripsThe control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the reactive strips. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Cystinuric patients, with or without urinary lithiasis at the time of inclusion.
- Patients who accept their participation in the study and give their informed consent.
Key exclusion criteria (1 listed)
- Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.
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 |
|---|---|---|
| Lit-control®pH MeterAlkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter. | Device | Lit-control®pH Meter |
| Reactive stripsAlkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips. | Diagnostic test | Reactive strips |
Primary outcome
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
Time frame: 183 measurements (morning) in 6 months.
Urinary pH measurement
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
Time frame: 183 measurements (afternoon) in 6 months.
Urinary pH measurement
Measurement of the volume of crystalluria.
Time frame: 1 measurement at the moment of enrollment
volume of crystalluria
Measurement of the volume of crystalluria.
Time frame: 1 measurement at 6 months
volume of crystalluria
Blood: DNA extraction.
Time frame: 1 measurement at the moment of enrollment
Extraction of DNA for genetic study of mutations for cystinuria.
Sediment analysis for the determination of urinary infection.
Time frame: 1 measurement at the moment of enrollment
Sediment analysis for the determination of Ulcer Index (UI)
Sediment analysis for the determination of urinary infection.
Time frame: 1 measurement at 6 months
Sediment analysis for the determination of UI
Total time within the margins established as safe in the pH control (months).
Time frame: 1 measurement through study completion [up to 6 months]
Amount of time within the pH margins established as safe
Adherence level in pH measurements
Time frame: Through study completion, fraction of pH measurements on the total possible. [up to 6 months]
% compliance of the pH measurements
Adherence level to treatment
Time frame: Through study completion, fraction of intakes on the total possible. [up to 6 months]
% of the intakes of the medication.
Total number of adverse events reported.
Time frame: Through study completion, number of events. [up to 6 months]
Amount of adverse events reported
Blood Analysis. Glucose
Time frame: Change from Baseline measurement at 6 months
Glucose in mmol/L
Blood Analysis. Calcium phosphate
Time frame: Change from Baseline measurement at 6 months
calcium phosphate in µmol/L
Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)
Time frame: Change from Baseline measurement at 6 months
estimated FG CKD-EPI
Blood Analysis. Cystatin
Time frame: Change from Baseline measurement at 6 months
cystatin in mg/L (to be measured only if estimated FG> 45 or <ml /min / 1.73 m2 and albumin / creatinine in the urine <3 mg / mmol)
Blood Analysis. Creatinine
Time frame: Change from Baseline measurement at 6 months
creatinine in µmol/L
Blood Analysis. Urate
Time frame: Change from Baseline measurement at 6 months
urate in μmol/L
24h Urine Analysis. Weight
Time frame: Change from Baseline measurement at 6 months
Weight in kg
24h Urine Analysis. Size
Time frame: Change from Baseline measurement at 6 months
Size in m
24h Urine Analysis. Urinary volume
Time frame: Change from Baseline measurement at 6 months
Urinary volume in L
24h Urine Analysis. Calcium phosphate
Time frame: Change from Baseline measurement at 6 months
calcium phosphate in µmol/L
24h Urine Analysis. Citrate
Time frame: Change from Baseline measurement at 6 months
citrate in μmol/L
24h Urine Analysis. Urate
Time frame: Change from Baseline measurement at 6 months
urate in μmol/L
24h Urine Analysis. Magnesium
Time frame: Change from Baseline measurement at 6 months
magnesium in μmol/L
24h Urine Analysis. Sodium
Time frame: Change from Baseline measurement at 6 months
sodium in μmol/L
24h Urine Analysis. BMI
Time frame: Change from Baseline measurement at 6 months
weight and height will be combined to report BMI in kg/m^2
24h Urine Analysis. Potassium
Time frame: Change from Baseline measurement at 6 months
potassium in μmol/L
24h Urine Analysis. Urea
Time frame: Change from Baseline measurement at 6 months
urea in µmol/L
Urine for the study of crystalluria. Schedule
Time frame: Change from Baseline measurement at 6 months
First urine of the morning (totality) for the study of crystalluria. Patient will provide the last hour of urination and hour of urine obtention in the morning.
Urine for the study of crystalluria. Crystalline volume
Time frame: Change from Baseline measurement at 6 months
overall crystalline volume (μm3 / mL)
Urine for the study of crystalluria. Crystals
Time frame: Change from Baseline measurement at 6 months
type and number of crystals (crystals / μL)
Urine for the study of crystalluria. Urine volume
Time frame: Change from Baseline measurement at 6 months
urine volume in L
Urine for the study of crystalluria. pH
Time frame: Change from Baseline measurement at 6 months
pH
Urine for the study of crystalluria. Size
Time frame: Change from Baseline measurement at 6 months
size in μm
Urine for the study of crystalluria. Density
Time frame: Change from Baseline measurement at 6 months
Density in mg / mL.
Urine for the study of crystalluria. Aggregation
Time frame: Change from Baseline measurement at 6 months
aggregation
Urine for the study of crystalluria. Twinning
Time frame: Change from Baseline measurement at 6 months
twinning
Urine for the study of crystalluria. Quotient
Time frame: Change from Baseline measurement at 6 months
Quotient albumin / creatinine
3 secondary outcomes
Sociodemographic and anthropometric questionnaire.
Time frame: 1 day of enrollment
Patient satisfaction questionnaire with the pH measurement method
Time frame: 3 times in 6 months
Physician satisfaction questionnaire with the pH measurement method
Time frame: 3 times in 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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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.
Oriol Angerri, MD principal investigator
Fundacio Puigvert
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive strips in people with Cystinuria, run by Devicare S.L. at 1 site in Spain.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Nov 2018. 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 Spain. 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?
Results are not available in the source record.
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 days with pH levels within range 7 and 8, during 6 months of home self-monitoring. (time frame: 183 measurements (morning) in 6 months.). The study lists 38 primary outcomes in all. 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 21 Nov 2018.