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

NCT07037953 | Completed

• 1 other identifier: 11551
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease Requiring Hemodialysis; Chronic Kidney Disease

Keywords

circRNAs; erythropoietin resistance; microRNAs; kidney failure

Outcome Measures

Primary Outcomes (3)

• SOX7 protein assays

  Serum SOX7 protein levels determined using Human Transcription Factor SOX7 ELISA kit

  Baseline or Day 1

• circ_DLGAP4 gene expression

  quantitative PCR, for circ\_DLGAP4 according to the kit manufacturer's recommendations.

  Baseline at Day 1

• miR-9-5p gene expression

  quantitative PCR for miR-9-5p (MIMAT0000441) according to the manufacturer's kit recommendations.

  Baseline at Day 1

Secondary Outcomes (1)

• ESA hypo-responsiveness index (EHRI)

  Baseline or at Day 1

Study Arms (3)

Control group

60 healthy controls

non-HD group

60 CKD patients not receiving hemodialysis (non-HD) group

HD Group

\[60 CKD Grade 5 patients undergoing MHD\]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

180 adult participants allocated into 3 groups: control group : 60 healthy volunteers served as controls (age range 33-72 years, 28 males, 32 females), and non-HD group : 60 CKD patients without HD (CKD G2-G4, age range 45-60 years, 29 males, 31 females), and HD group : 60 CKD patients undergoing MHD (CKD G5, age range 44-67 years, 30 males, 30 females).

You may qualify if:

• 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.

You may not qualify if:

• Subjects having \< 18 years of age,
• non-compliant persons,
• smokers,
• patients with low risk of CKD (category G1),
• kidney transplant recipients,
• individuals in critical conditions, those with acute kidney injury, ischemic heart disease, cancer, or those receiving chemotherapy, or having cognitive impairment

Sponsors & Collaborators

• Ain Shams University: lead
• Egyptian Chinese University: collaborator
• Kasr El Aini Hospital: collaborator

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Sabry, PhD

  Clinical pharmacy department, Faculty of pharmacy and drug technology, Egyptian Chinese University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 26, 2025
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-06

Locations

EG (1)