Renal Impact of KAFTRIO in Mucoviscidose Population

N/AUnknownNCT06197490

Hospices Civils de Lyon20 enrolled

Overview

The objective of this study is to describe the renal impact of Elexacaftor-Teacaftor-Ivacaftor, a triple modulator therapy of CFTR channel, in patients with cystic fibrosis. This new treatment acts on the CFTR channel, which is expressed at the level of the nephrons. The objective is to study the changes in plasma and urinary parameters, including metabolic explorations of urolithiasis, change in volemic parameters, renal function, urinary sediment and nutritional and glycemic parameters, in newly treated patients, through the data collected at introduction of the treatment and during the follow-up.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cystic Fibrosis

Interventions

Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiationBIOLOGICAL

Collection of Uricuria, phosphaturie, calciuria, magnesuria, glycosuria, citraturia, oxaluria, before and after initiation of KAFTRIO

Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiationDRUG

Arterial pressure, glycemia, glycated hemoglobin, lipid profile, weight, serum and urinary electrolytes, hepatic check, complete blood count, calcium phosphate balance and urinary sediment analysis before and after initiation of KAFTRIO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with cystic fibrosis * More than 18 years old * Eligible for KAFTRIO Exclusion Criteria: * KAFTRIO contraindication * Patient less than 18 years old * Dialysis patient * Pregnant woman * Greffed patient * Patient opposition to data collection

Locations (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

Outcomes

Primary Outcomes

Modification of the parameters of the lithiasis assessment

Change in blood phosphorus and calcium metabolism ; Change in calciuria mmol/d ;Change in urinary pH, urinary specific gravity (g/mL) and crystalluria

Time frame: 1 month after initiation of KAFTRIO

Modification of the parameters of the lithiasis assessment

Change in blood phosphorus and calcium metabolism ; Change in calciuria mmol/d ;Change in urinary pH, urinary specific gravity (g/mL) and crystalluria

Time frame: 7 months after initiation of KAFTRIO

Secondary Outcomes

Change in volemic parameter

body mass index (BMI) (kg/m²), systolic and diastolic blood pressure (mmHg), presence of orthostatic hypotension, renin and aldosterone levels and ratio (ng/L and pmol/L respectively), natremia (mmol/L), natriuresis (mmol/d), kalemia (mmol/L), kaliuresis (mmol/d), chloremia (mmol/L), bicarbonatemia (mmol/L), brain natriuretic peptid (ng/L), hemoglobin (g/L) and sodium intake estimated by the dietician and calculated thanks to natriuresis (g/d)

Time frame: 1 month after initiation of KAFTRIO

Change in volemic parameter

Time frame: 7 month after initiation of KAFTRIO

Change in renal function

(measured using creatinine (µmol/L) and cystatin C (mg/L)combined to report 2021 CKD-EPIcreatinineand CKD-EPIcreatinine-cystatin C formulas) and in plasma urea levels (mmol/L).

Central Contacts

Etienne NOVEL CATIN

CONTACT

04.72.67.87.37 etienne.novel-catin@chu-lyon.fr

Data from ClinicalTrials.gov

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