Serum circ_DLGAP4, lncRNA KCNQ1OT1, and Their Targets by Erythropoietin Resistance in Chronic Kidney Disease

Non-coding RNAs have evolved as biomarkers and as phased and specific therapeutic targets for chronic kidney disease (CKD). However, their clinical significance in CKD patients is largely unexplored. Anemia resistant to erythropoietin-stimulating agents (ESAs) is a risk factor for all-cause mortality of CKD patients. This study investigated the potential association of serum circ\_DLGAP4, lncRNA KCNQ1OT1, miR-9, and their target SOX7 with the early diagnosis, prognosis, and worse clinical outcomes in CKD patients with different stages, including those on maintenance hemodialysis (MHD). The clinical correlations of these markers in CKD patients were explored; particularly their possible association with ESA resistance in MHD patients. An analytical observational case-controlled cross-sectional study was conducted on CKD patients. Participants were enrolled to control group \[60 healthy controls\], on-hemodialysis (non-HD) group \[60 CKD Grade 2-4 patients with no hemodialysis\], and hemodialysis (HD) Group \[60 CKD Grade 5 patients undergoing MHD\]. Demographic, clinical, laboratory data, and drug history were recorded. ESA hypo-responsiveness index (EHRI) was calculated. Molecular pathway analysis was conducted using bioinformatics. RT-qPCR and ELISA techniques were used in gene expression and SOX7 protein assays, respectively.

NCT Number	NCT07037953
Lead Sponsor	Ain Shams University Collaborators: Egyptian Chinese University, Kasr El Aini Hospital
Conditions	Chronic Kidney Disease Requiring Hemodialysis, Chronic Kidney Disease
Enrollment	180 participants
Start Date	2024-08-01
Primary Completion	2025-01-01 (estimated)
Study Completion	2025-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-07