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NCT07037953Completed

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

Association of Serum circ_DLGAP4, lncRNA KCNQ1OT1, and Their Targets miR-9 and SOX7 With Early Diagnosis, Erythropoietin Resistance and Worse Clinical Outcomes of Chronic Kidney Disease: Insights From Hemodialysis Patients

Source: ClinicalTrials.gov · Last updated 7 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
180 (actual)
First submitted
10 Jun 2025
Start date
Aug 2024
Primary completion date
Jan 2025
Lead sponsor
Ain Shams University
NCT number
NCT07037953

What you commit to

  • Study type: Observational
  • Participants enrolled: 180
  • From Aug 2024 to the primary completion date, Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • kidney transplant recipients,
  • individuals in critical conditions, those with acute kidney injury, ischemic heart disease, cancer, or those receiving chemotherapy, or having cognitive impairment

Age

  • Subjects having \< 18 years of age,

Other

  • non-compliant persons,
  • smokers,
  • patients with low risk of CKD (category G1),

Who the study is looking for

  • adult patients (\> 18 years) with a final clinical diagnosis of CKD with a category G2-G5
  • mild to severe albuminuria (A1-A3),
  • patients with an eGFR \< 15 mL/min/1.73 m2 (kidney failure or ESKD) undergoing HD.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Unit of Renal Failure Therapy and Surgery, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo, Egypt, and the Hemodialysis Unit, New Cairo Specialized Hospital, Cairo, Egypt
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.