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).

NCT03539926 | Unknown

• 1 other identifier: DEV-LCD-01-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystinuria

Keywords

Cystinuria; pH Control

Outcome Measures

Primary Outcomes (38)

• 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 Outcomes (3)

• Sociodemographic and anthropometric questionnaire.

  1 day of enrollment

• Patient satisfaction questionnaire with the pH measurement method

  3 times in 6 months

• Physician satisfaction questionnaire with the pH measurement method

  3 times in 6 months

Study Arms (2)

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.

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.

Diagnostic Test: Reactive strips

Interventions

Lit-control®pH Meter DEVICE

Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.

Lit-control®pH Meter

Reactive strips DIAGNOSTIC_TEST

Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.

Reactive strips

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old.
• Patients who accept their participation in the study and give their informed consent.

You may not qualify if:

• Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.

Sponsors & Collaborators

• Devicare S.L.: lead
• Clever Instruments S.L.: collaborator
• Fundacio Puigvert: collaborator

Study Sites (1)

Fundacio Puigvert

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Cystinuria

Condition Hierarchy (Ancestors)

Renal Aminoacidurias; Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Oriol Angerri, MD

  Fundacio Puigvert

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 30, 2018
• Study Start: April 9, 2018
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

ES (1)