Renal Impact of KAFTRIO in Mucoviscidose Population

Cystic Fibrosis Clinical Trial

— IRT-MUCO  

Official title:

Renal Impact of KAFTRIO in Mucoviscidose Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197490
• Other study ID #: 22-5080
• Secondary ID: 69HCL23_1169
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: Etienne NOVEL CATIN
• Phone: 04.72.67.87.37
• Email: etienne.novel-catin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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