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).

• Sponsor: Devicare S.L. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03539926
• Collaborator: Clever Instruments S.L. (Industry), Fundacio Puigvert (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.8
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cystinuria	Device: Lit-control®pH Meter; Diagnostic Test: Reactive strips	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• 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).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
• 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
• Actual Study Start Date: Apr 9, 2018
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	Diagnostic Test: Reactive strips; Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.

Outcome Measures

Primary Outcome Measures

1. Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring. [183 measurements (morning) in 6 months.]

   Urinary pH measurement

2. Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring. [183 measurements (afternoon) in 6 months.]

   Urinary pH measurement

3. Measurement of the volume of crystalluria. [1 measurement at the moment of enrollment]

   volume of crystalluria

4. Measurement of the volume of crystalluria. [1 measurement at 6 months]

   volume of crystalluria

5. Blood: DNA extraction. [1 measurement at the moment of enrollment]

   Extraction of DNA for genetic study of mutations for cystinuria.

6. Sediment analysis for the determination of urinary infection. [1 measurement at the moment of enrollment]

   Sediment analysis for the determination of Ulcer Index (UI)

7. Sediment analysis for the determination of urinary infection. [1 measurement at 6 months]

   Sediment analysis for the determination of UI

8. Total time within the margins established as safe in the pH control (months). [1 measurement through study completion [up to 6 months]]

   Amount of time within the pH margins established as safe

9. Adherence level in pH measurements [Through study completion, fraction of pH measurements on the total possible. [up to 6 months]]

   % compliance of the pH measurements

10. Adherence level to treatment [Through study completion, fraction of intakes on the total possible. [up to 6 months]]

    % of the intakes of the medication.

11. Total number of adverse events reported. [Through study completion, number of events. [up to 6 months]]

    Amount of adverse events reported

12. Blood Analysis. Glucose [Change from Baseline measurement at 6 months]

    Glucose in mmol/L

13. Blood Analysis. Calcium phosphate [Change from Baseline measurement at 6 months]

    calcium phosphate in µmol/L

14. Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI) [Change from Baseline measurement at 6 months]

    estimated FG CKD-EPI

15. Blood Analysis. Cystatin [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)

16. Blood Analysis. Creatinine [Change from Baseline measurement at 6 months]

    creatinine in µmol/L

17. Blood Analysis. Urate [Change from Baseline measurement at 6 months]

    urate in μmol/L

18. 24h Urine Analysis. Weight [Change from Baseline measurement at 6 months]

    Weight in kg

19. 24h Urine Analysis. Size [Change from Baseline measurement at 6 months]

    Size in m

20. 24h Urine Analysis. Urinary volume [Change from Baseline measurement at 6 months]

    Urinary volume in L

21. 24h Urine Analysis. Calcium phosphate [Change from Baseline measurement at 6 months]

    calcium phosphate in µmol/L

22. 24h Urine Analysis. Citrate [Change from Baseline measurement at 6 months]

    citrate in μmol/L

23. 24h Urine Analysis. Urate [Change from Baseline measurement at 6 months]

    urate in μmol/L

24. 24h Urine Analysis. Magnesium [Change from Baseline measurement at 6 months]

    magnesium in μmol/L

25. 24h Urine Analysis. Sodium [Change from Baseline measurement at 6 months]

    sodium in μmol/L

26. 24h Urine Analysis. BMI [Change from Baseline measurement at 6 months]

    weight and height will be combined to report BMI in kg/m^2

27. 24h Urine Analysis. Potassium [Change from Baseline measurement at 6 months]

    potassium in μmol/L

28. 24h Urine Analysis. Urea [Change from Baseline measurement at 6 months]

    urea in µmol/L

29. Urine for the study of crystalluria. Schedule [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.

30. Urine for the study of crystalluria. Crystalline volume [Change from Baseline measurement at 6 months]

    overall crystalline volume (μm3 / mL)

31. Urine for the study of crystalluria. Crystals [Change from Baseline measurement at 6 months]

    type and number of crystals (crystals / μL)

32. Urine for the study of crystalluria. Urine volume [Change from Baseline measurement at 6 months]

    urine volume in L

33. Urine for the study of crystalluria. pH [Change from Baseline measurement at 6 months]

    pH

34. Urine for the study of crystalluria. Size [Change from Baseline measurement at 6 months]

    size in μm

35. Urine for the study of crystalluria. Density [Change from Baseline measurement at 6 months]

    Density in mg / mL.

36. Urine for the study of crystalluria. Aggregation [Change from Baseline measurement at 6 months]

    aggregation

37. Urine for the study of crystalluria. Twinning [Change from Baseline measurement at 6 months]

    twinning

38. Urine for the study of crystalluria. Quotient [Change from Baseline measurement at 6 months]

    Quotient albumin / creatinine

Secondary Outcome Measures

1. Sociodemographic and anthropometric questionnaire. [1 day of enrollment]

   Family and personal background and general data (sex, age, etc.).

2. Patient satisfaction questionnaire with the pH measurement method [3 times in 6 months]

   Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)

3. Physician satisfaction questionnaire with the pH measurement method [3 times in 6 months]

   Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacio Puigvert	Barcelona		Spain	08025

Sponsors and Collaborators

• Devicare S.L.
• Clever Instruments S.L.
• Fundacio Puigvert

Investigators

• Principal Investigator: Oriol Angerri, MD, Fundacio Puigvert

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Devicare S.L.
• ClinicalTrials.gov Identifier: NCT03539926
• Other Study ID Numbers: DEV-LCD-01-17
• First Posted: May 30, 2018
• Last Update Posted: Nov 21, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Devicare S.L.: Cystinuria; pH Control
• Additional relevant MeSH terms: Cystinuria

Study Results

No Results Posted as of Nov 21, 2018