NCT06197490

Renal Impact of KAFTRIO in Mucoviscidose Population

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation	Collection of Uricuria, phosphaturie, calciuria, magnesuria, glycosuria, citraturia, oxaluria, before and after initiation of KAFTRIO
DRUG	Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation	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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-01-09
• Last updated: 2024-01-09

Locations

1 site across 1 country: France