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Renal Impact of KAFTRIO in Mucoviscidose Population

NCT06197490 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-01-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Etienne NOVEL-CATIN, MD · Hospices Civils de Lyon

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197490 on ClinicalTrials.gov