Cystic FibrosisIRT-MUCONCT06197490
Renal Impact of KAFTRIO in Mucoviscidose Population
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation and Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with cystic fibrosis followed at Centre Hospitalier Lyon Sud (in the reference and competence center for cystic fibrosis)
Who may be able to join
- Patient with cystic fibrosis
- More than 18 years old
- Eligible for KAFTRIO
Who cannot join
- KAFTRIO contraindication
- Patient less than 18 years old
- Dialysis patient
- Pregnant woman
- Greffed patient
- Patient opposition to data collection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Etienne NOVEL-CATIN, MD, 04.72.67.87.37, etienne.novel-catin@chu-lyon.fr
About this study
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
- Being tested
- Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation, Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation
- Keywords
- cystic fibrosis, KAFTRIO, renal impact, lithiasis
- Medical subject headings
- Cystic Fibrosis, Lithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiationBiological
Collection of Uricuria, phosphaturie, calciuria, magnesuria, glycosuria, citraturia, oxaluria, before and after initiation of KAFTRIO
Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiationDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with cystic fibrosis, eligible for KAFTRIO therapy | Patient with cystic fibrosis, eligible for KATRIO, over 18 years old. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 months after initiation of KAFTRIO
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 7 month after initiation of KAFTRIO
Change in lung function
predicted forced expiratory volume in 1 second (FEV1) (%) and peak expiratory flow (%)).
Measured: 1 month after initiation of KAFTRIO
Change in lung function
predicted forced expiratory volume in 1 second (FEV1) (%) and peak expiratory flow (%)).
Measured: 7 month after initiation of KAFTRIO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne NOVEL-CATIN, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197490
- Sponsor's protocol ID
- 22-5080
- Other IDs
- 69HCL23_1169
- Acronym
- IRT-MUCO
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Impact of KAFTRIO in Mucoviscidose Population
- ClinicalTrials.gov ID
- NCT06197490
- Acronym / sponsor ID
- IRT-MUCO / 22-5080
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, KAFTRIO, renal impact, lithiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with cystic fibrosis, eligible for KAFTRIO therapy | – | 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 initiationPatient with cystic fibrosis, eligible for KATRIO, over 18 years old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with cystic fibrosis followed at Centre Hospitalier Lyon Sud (in the reference and competence center for cystic fibrosis)
Key inclusion criteria (3 listed)
- Patient with cystic fibrosis
- More than 18 years old
- Eligible for KAFTRIO
Key exclusion criteria (6 listed)
- KAFTRIO contraindication
- Patient less than 18 years old
- Dialysis patient
- Pregnant woman
- Greffed patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiationCollection of Uricuria, phosphaturie, calciuria, magnesuria, glycosuria, citraturia, oxaluria, before and after initiation of KAFTRIO | Biological | Patient with cystic fibrosis, eligible for KAFTRIO therapy |
| Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiationArterial 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 | Drug | Patient with cystic fibrosis, eligible for KAFTRIO therapy |
Primary outcome
Modification of the parameters of the lithiasis assessment
Time frame: 1 month after initiation of KAFTRIO
Change in blood phosphorus and calcium metabolism ; Change in calciuria mmol/d ;Change in urinary pH, urinary specific gravity (g/mL) and crystalluria
Modification of the parameters of the lithiasis assessment
Time frame: 7 months after initiation of KAFTRIO
Change in blood phosphorus and calcium metabolism ; Change in calciuria mmol/d ;Change in urinary pH, urinary specific gravity (g/mL) and crystalluria
10 secondary outcomes
Change in volemic parameter
Time frame: 1 month after initiation of KAFTRIO
Change in volemic parameter
Time frame: 7 month after initiation of KAFTRIO
Change in renal function
Time frame: 1 month after initiation of KAFTRIO
Change in renal function
Time frame: 7 month after initiation of KAFTRIO
Change in urinary sediment
Time frame: 1 month after initiation of KAFTRIO
Change in urinary sediment
Time frame: 7 month after initiation of KAFTRIO
Change in glycemic profile
Time frame: 1 month after initiation of KAFTRIO
Change in glycemic profile
Time frame: 7 month after initiation of KAFTRIO
Change in lung function
Time frame: 1 month after initiation of KAFTRIO
Change in lung function
Time frame: 7 month after initiation of KAFTRIO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne NOVEL-CATIN, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etienne NOVEL CATIN (04.72.67.87.37 ext. +33, etienne.novel-catin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of the parameters of the lithiasis assessment (time frame: 1 month after initiation of KAFTRIO). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.