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| ID | Type | Description | Link |
|---|---|---|---|
| 69HCL23_1169 | Other Identifier | Easydore |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with cystic fibrosis, eligible for KAFTRIO therapy | Patient with cystic fibrosis, eligible for KATRIO, over 18 years old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation | Biological | Collection of Uricuria, phosphaturie, calciuria, magnesuria, glycosuria, citraturia, oxaluria, before and after initiation of KAFTRIO |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with cystic fibrosis followed at Centre Hospitalier Lyon Sud (in the reference and competence center for cystic fibrosis)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Etienne NOVEL CATIN | Contact | 04.72.67.87.37 | +33 | etienne.novel-catin@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Etienne NOVEL-CATIN, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
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| Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation | Drug | 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 |
|
| 1 month after initiation of KAFTRIO |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in lung function | predicted forced expiratory volume in 1 second (FEV1) (%) and peak expiratory flow (%)). | 1 month after initiation of KAFTRIO |
| Change in lung function | predicted forced expiratory volume in 1 second (FEV1) (%) and peak expiratory flow (%)). | 7 month after initiation of KAFTRIO |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D020347 | Lithiasis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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