Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
NCT07498335
Autoimmune Diseases, Berger Disease
Neptune City, New Jersey, United States
View Trial DetailsNCT Number: NCT05190848
IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.
Interested in participating?
Request Info16 year–65 year
All sexes
Observational
Sun Yat-sen Memorial Hospital Sun Yat-sen university, Guangzhou, Guangdong, China
IgAN-microbiome is an investigator-initiated,multi-center,Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.
Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Death for any reason.
Time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
not meet the entry criteria for any reason
Contact information is provided by the study sponsor or research team.
Fengtao Cai
CONTACT
Xueqing Yu
CONTACT
Guangdong Provincial People's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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