Renal Impact of KAFTRIO in Mucoviscidose Population (IRT-MUCO)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Cystic Fibrosis

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT06197490

69HCL23_1169 (Other Identifier)

22-5080

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Patient with cystic fibrosis, eligible for KAFTRIO therapy

Description:

Patient with cystic fibrosis, eligible for KATRIO, over 18 years old.

Treatment:

Drug: Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation

Biological: Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation