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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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539926
Recruitment Status : Active, not recruiting
First Posted : May 30, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Clever Instruments S.L.
Fundacio Puigvert
Information provided by (Responsible Party):
Devicare S.L.

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE April 9, 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • Sociodemographic and anthropometric questionnaire. [ Time Frame: 1 day of enrollment ]
    Family and personal background and general data (sex, age, etc.).
  • Patient satisfaction questionnaire with the pH measurement method [ Time Frame: 3 times in 6 months ]
    Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)
  • Physician satisfaction questionnaire with the pH measurement method [ Time Frame: 3 times in 6 months ]
    Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Sociodemographic and anthropometric questionnaire. [ Time Frame: 1 day of enrollment ]
    Family and personal background and general data (sex, age, etc.).
  • Scale questionnaire of the patient's satisfaction degree with the pH measurement method. [ Time Frame: 3 times in 6 months ]
    Scale questionnaire of the patient's satisfaction degree
  • Scale questionnaire of the patient's comfort degree with the device. [ Time Frame: 3 times in 6 months ]
    Scale questionnaire of the patient's comfort degree
  • Scale questionnaire of the physician satisfaction degree with the pH control by Lit-control®pH Meter. [ Time Frame: 3 times in 6 months ]
    Scale questionnaire of the physician satisfaction degree
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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).
Official Title  ICMJE 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
Brief 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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description:
The process of randomization, either device use or use of strips, will be masked until the moment it is delivered to the patient. The random assignment to each product will be made through lists created by an ad hoc computer program.
Primary Purpose: Other
Condition  ICMJE Cystinuria
Intervention  ICMJE
  • Device: Lit-control®pH Meter
    Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
  • Diagnostic Test: Reactive strips
    Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
Study Arms  ICMJE
  • Experimental: Lit-control®pH Meter
    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.
    Intervention: Device: Lit-control®pH Meter
  • Placebo Comparator: Reactive strips
    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.
    Intervention: Diagnostic Test: Reactive strips
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03539926
Other Study ID Numbers  ICMJE DEV-LCD-01-17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Devicare S.L.
Study Sponsor  ICMJE Devicare S.L.
Collaborators  ICMJE
  • Clever Instruments S.L.
  • Fundacio Puigvert
Investigators  ICMJE
Principal Investigator: Oriol Angerri, MD Fundacio Puigvert
PRS Account Devicare S.L.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP