Kidney Function in People With Cystic Fibrosis in the Era of HEMT
NCT ID: NCT06595420
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
260 participants
OBSERVATIONAL
2025-01-09
2027-12-31
Brief Summary
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Detailed Description
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The study involves prospective evaluation of biospecimens (blood and urine) and clinical data. The study analyzes biospecimens in CF outpatients (n=110), CF inpatients (n=110), and healthy subjects (n=40). In the outpatient cohort, biospecimens will be collected at the time of each routine care visit every 3 months for 24 months. PwCF admitted for intravenous (IV) antibiotics will have biospecimens collected on admission and every 48 hrs thereafter during the admission, and then after hospital discharge at each subsequent clinical encounter for 24 months.
These biospecimens will be analyzed for biomarkers, fibrogenic analysis, inflammatory signals, and extracellular vesicles. Clinical data will be examined from chart review and correlated with biospecimen result.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Outpatient CF Cohort
Not hospitalized CF group: Diagnosis of CF, age \>30 y, with ongoing care at one of the 3 CF Centers (Dartmouth, UAB, UVA).
No interventions assigned to this group
Inpatient CF Cohort
Hospitalized CF cohort: Diagnosis of CF, age \>7 y, being admitted for intravenous antibiotic treatment of pulmonary exacerbation.
No interventions assigned to this group
Healthy Controls
Healthy Volunteers without CF
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnoses of Cystic Fibrosis
* Age \> 30 years old
* Able to provide informed consent
2. Inpatient CF Cohort
* Diagnoses of Cystic Fibrosis
* Age \> 7 years old
* Able to provide informed consent and assent (where applicable)
* 55 PwCF frequently hospitalized for a pulmonary exacerbation (\>1 hospital admission in the prior 12 months)
* 55 PwCF sporadically hospitalized for a pulmonary exacerbation (no hospital admissions in the prior 12 months)
* Able to provide urine sample independently
3. Healthy Controls
* Healthy, as per participant self-report
* Age between 30-50 years
* Able to provide informed consent
Exclusion Criteria
* History of any organ transplant
* History of immunodeficiency
* Previous or current cancer diagnoses
* Pregnant or breastfeeding
* On chronic dialysis
* Non-compliance (demonstrated by \<2 visits during the 12 months before enrollment)
2. Inpatient CF Cohort
* The initiation of intravenous antibiotic therapy after hospital admission before obtaining the first blood and urine sample
* History of any organ transplant
* History of immunodeficiency
* Previous or current cancer diagnoses
* Pregnant or breastfeeding
* On chronic dialysis
3. Healthy Controls
* History or current kidney disease, organ transplantation, cancer, or any other chronic illness
* Current use of antibiotics
* Urinary symptoms or UTI (dysuria, frequency, urgency)
* Pregnant women
* Menstruating on the study visit day
* Blood relatives of PwCF
7 Years
ALL
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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Agnieszka Swiatecka-Urban
Professor of Pediatrics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire, United States
University of Virginia Children's Hospital
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Devuyst O, Burrow CR, Schwiebert EM, Guggino WB, Wilson PD. Developmental regulation of CFTR expression during human nephrogenesis. Am J Physiol. 1996 Sep;271(3 Pt 2):F723-35. doi: 10.1152/ajprenal.1996.271.3.F723.
Southern KW. Acute renal failure in people with cystic fibrosis. Thorax. 2007 Jun;62(6):472-3. doi: 10.1136/thx.2006.072355.
Al-Aloul M, Miller H, Alapati S, Stockton PA, Ledson MJ, Walshaw MJ. Renal impairment in cystic fibrosis patients due to repeated intravenous aminoglycoside use. Pediatr Pulmonol. 2005 Jan;39(1):15-20. doi: 10.1002/ppul.20138.
Bertenshaw C, Watson AR, Lewis S, Smyth A. Survey of acute renal failure in patients with cystic fibrosis in the UK. Thorax. 2007 Jun;62(6):541-5. doi: 10.1136/thx.2006.067595. Epub 2007 Jan 18.
Quon BS, Mayer-Hamblett N, Aitken ML, Smyth AR, Goss CH. Risk factors for chronic kidney disease in adults with cystic fibrosis. Am J Respir Crit Care Med. 2011 Nov 15;184(10):1147-52. doi: 10.1164/rccm.201105-0932OC. Epub 2011 Jul 28.
Stevanovic M, G.M. Primary Causes of ESRD in the US Cystic Fibrosis Population. JASN 33, 694
Stevanovic, M.G.M.L. Characteristics of US Individuals with Cystic Fibrosis and ESRD. JASN 33, 694
Lai S, Mazzaferro S, Mitterhofer AP, Bonci E, Marotta PG, Pelligra F, Murciano M, Celani C, Troiani P, Cimino G, Palange P. Renal involvement and metabolic alterations in adults patients affected by cystic fibrosis. J Transl Med. 2019 Nov 25;17(1):388. doi: 10.1186/s12967-019-02139-4.
Berg KH, Ryom L, Faurholt-Jepsen D, Pressler T, Katzenstein TL. Prevalence and characteristics of chronic kidney disease among Danish adults with cystic fibrosis. J Cyst Fibros. 2018 Jul;17(4):478-483. doi: 10.1016/j.jcf.2017.11.001. Epub 2017 Dec 1.
Alicandro G, Frova L, Di Fraia G, Colombo C. Cystic fibrosis mortality trend in Italy from 1970 to 2011. J Cyst Fibros. 2015 Mar;14(2):267-74. doi: 10.1016/j.jcf.2014.07.010. Epub 2014 Aug 20.
Nazareth D, Walshaw M. A review of renal disease in cystic fibrosis. J Cyst Fibros. 2013 Jul;12(4):309-17. doi: 10.1016/j.jcf.2013.03.005. Epub 2013 Apr 22.
van Duijl TT, Ruhaak LR, de Fijter JW, Cobbaert CM. Kidney Injury Biomarkers in an Academic Hospital Setting: Where Are We Now? Clin Biochem Rev. 2019 May;40(2):79-97. doi: 10.33176/AACB-18-00017.
Kovesdy CP, Bleyer AJ, Molnar MZ, Ma JZ, Sim JJ, Cushman WC, Quarles LD, Kalantar-Zadeh K. Blood pressure and mortality in U.S. veterans with chronic kidney disease: a cohort study. Ann Intern Med. 2013 Aug 20;159(4):233-42. doi: 10.7326/0003-4819-159-4-201308200-00004.
Breyer MD, Susztak K. The next generation of therapeutics for chronic kidney disease. Nat Rev Drug Discov. 2016 Aug;15(8):568-88. doi: 10.1038/nrd.2016.67. Epub 2016 May 27.
Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18.
Other Identifiers
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005245A123
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSR231650
Identifier Type: -
Identifier Source: org_study_id
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