Renal Impact of KAFTRIO in Mucoviscidose Population

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Biological: Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation; Drug: Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation

• Registration Number: NCT06197490
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with cystic fibrosis, eligible for KAFTRIO therapy	Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation	Patient with cystic fibrosis, eligible for KATRIO, over 18 years old.
Patient with cystic fibrosis, eligible for KAFTRIO therapy	Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation	Patient with cystic fibrosis, eligible for KATRIO, over 18 years old.

Primary Outcome Measures

Name	Time	Method
Modification of the parameters of the lithiasis assessment	7 months after initiation of KAFTRIO	Change in blood phosphorus and calcium metabolism ; Change in calciuria mmol/d ;Change in urinary pH, urinary specific gravity (g/mL) and crystalluria

Secondary Outcome Measures

Name	Time	Method
Change in urinary sediment	7 month after initiation of KAFTRIO	, represented by proteinuria (g/day), albuminuria/creatininuria ratio (mg/g) and urinary beta-2-microglobulin level (mg/day), after collecting 24-hours urine sa
Change in lung function	7 month after initiation of KAFTRIO	predicted forced expiratory volume in 1 second (FEV1) (%) and peak expiratory flow (%)).
Change in renal function	7 month after initiation of KAFTRIO	(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).
Change in volemic parameter	7 month after initiation of KAFTRIO	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)
Change in glycemic profile	7 month after initiation of KAFTRIO	(fasting blood glucose level (mmol/L) and glycated hemoglobin (%)) and nutritional profile (albumin and pre-albumin in g/L).

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France