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).

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).

Study Overview

• Status: Unknown
• Conditions: Cystinuria
• Intervention / Treatment: Device: Lit-control®pH Meter; Diagnostic test: Reactive strips

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Fundacio Puigvert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.	Urinary pH measurement	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	183 measurements (afternoon) in 6 months.
Measurement of the volume of crystalluria.	volume of crystalluria	1 measurement at the moment of enrollment
Measurement of the volume of crystalluria.	volume of crystalluria	1 measurement at 6 months
Blood: DNA extraction.	Extraction of DNA for genetic study of mutations for cystinuria.	1 measurement at the moment of enrollment
Sediment analysis for the determination of urinary infection.	Sediment analysis for the determination of Ulcer Index (UI)	1 measurement at the moment of enrollment
Sediment analysis for the determination of urinary infection.	Sediment analysis for the determination of UI	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	1 measurement through study completion [up to 6 months]
Adherence level in pH measurements	% compliance of the pH measurements	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.	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	Through study completion, number of events. [up to 6 months]
Blood Analysis. Glucose	Glucose in mmol/L	Change from Baseline measurement at 6 months
Blood Analysis. Calcium phosphate	calcium phosphate in µmol/L	Change from Baseline measurement at 6 months
Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)	estimated FG CKD-EPI	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)	Change from Baseline measurement at 6 months
Blood Analysis. Creatinine	creatinine in µmol/L	Change from Baseline measurement at 6 months
Blood Analysis. Urate	urate in μmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. Weight	Weight in kg	Change from Baseline measurement at 6 months
24h Urine Analysis. Size	Size in m	Change from Baseline measurement at 6 months
24h Urine Analysis. Urinary volume	Urinary volume in L	Change from Baseline measurement at 6 months
24h Urine Analysis. Calcium phosphate	calcium phosphate in µmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. Citrate	citrate in μmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. Urate	urate in μmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. Magnesium	magnesium in μmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. Sodium	sodium in μmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. BMI	weight and height will be combined to report BMI in kg/m^2	Change from Baseline measurement at 6 months
24h Urine Analysis. Potassium	potassium in μmol/L	Change from Baseline measurement at 6 months
24h Urine Analysis. Urea	urea in µmol/L	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.	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Crystalline volume	overall crystalline volume (μm3 / mL)	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Crystals	type and number of crystals (crystals / μL)	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Urine volume	urine volume in L	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. pH	pH	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Size	size in μm	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Density	Density in mg / mL.	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Aggregation	aggregation	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Twinning	twinning	Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Quotient	Quotient albumin / creatinine	Change from Baseline measurement at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic and anthropometric questionnaire.	Family and personal background and general data (sex, age, etc.).	1 day of enrollment
Patient satisfaction questionnaire with the pH measurement method	Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)	3 times in 6 months
Physician satisfaction questionnaire with the pH measurement method	Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied	3 times in 6 months

Collaborators and Investigators

• Sponsor: Devicare S.L.
• Collaborators: Clever Instruments S.L.; Fundacio Puigvert
• Investigators: Principal Investigator: Oriol Angerri, MD, Fundacio Puigvert

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Cystinuria; pH Control
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Renal Tubular Transport, Inborn Errors; Renal Aminoacidurias; Cystinuria
• Other Study ID Numbers: DEV-LCD-01-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No