NCT06197490

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 11, 2023

Last Update Submit

January 8, 2024

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisKAFTRIOrenal impactlithiasis

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (10)

  • Change in volemic parameter

    1 month after initiation of KAFTRIO

  • Change in volemic parameter

    7 month after initiation of KAFTRIO

  • Change in renal function

    1 month after initiation of KAFTRIO

  • Change in renal function

    7 month after initiation of KAFTRIO

  • Change in urinary sediment

    1 month after initiation of KAFTRIO

  • +5 more secondary outcomes

Study Arms (1)

Patient with cystic fibrosis, eligible for KAFTRIO therapy

Patient with cystic fibrosis, eligible for KATRIO, over 18 years old.

Biological: Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiationDrug: Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation

Interventions

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

Patient with cystic fibrosis, eligible for KAFTRIO therapy
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

Patient with cystic fibrosis, eligible for KAFTRIO therapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with cystic fibrosis followed at Centre Hospitalier Lyon Sud (in the reference and competence center for cystic fibrosis)

You may qualify if:

  • Patient with cystic fibrosis
  • More than 18 years old
  • Eligible for KAFTRIO

You may not qualify if:

  • KAFTRIO contraindication
  • Patient less than 18 years old
  • Dialysis patient
  • Pregnant woman
  • Greffed patient
  • Patient opposition to data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Cystic FibrosisLithiasis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Etienne NOVEL-CATIN, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne NOVEL CATIN

CONTACT

04.72.67.87.37etienne.novel-catin@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 9, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations

FR(1)