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Chronic Kidney Disease Requiring HemodialysisNCT07037953

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

An observational study of Chronic Kidney Disease Requiring Hemodialysis and Chronic Kidney Disease, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
180 participants
Where
1 siteEgypt
Study dates
1 Aug 2024to 1 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • 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

Other trials in Egypt

About this study

Official title: 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

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.

Read the detailed description

Chronic kidney disease (CKD) poses a rising global health challenge, with a median prevalence of 9.5%. In Egypt, an estimated 7.1 million individuals are affected, and the prevalence is expected to increase with the growing incidence of hypertension and diabetes. CKD is now the seventh leading global cause of death, particularly burdening low- and middle-income countries where access to kidney replacement therapy (KRT)-such as dialysis or transplantation-is limited and costly. Early detection and the identification of novel therapeutic targets are essential to delay disease progression and reduce adverse outcomes.

Although urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) are the clinical standards for CKD diagnosis and staging, both have significant limitations. These include variability, limited sensitivity/specificity, and confounding non-renal factors. Kidney biopsy, while more accurate, is invasive and not routinely feasible. Moreover, controlling traditional risk factors (e.g., hyperglycemia, hypertension) may still fail to prevent progression to end-stage kidney disease (ESKD), which is frequently complicated by anemia and early mortality. This highlights the urgent need for non-invasive, sensitive biomarkers that can aid in diagnosis, prognosis, and treatment guidance.

Non-coding RNAs (ncRNAs), including circular RNAs (circRNAs), long ncRNAs (lncRNAs), and microRNAs (miRNAs), are emerging as promising biomarkers due to their stability in circulation and tissue-specific expression. circRNAs, formed by back-splicing, regulate gene expression by acting as miRNA sponges and are implicated in various kidney disorders, including CKD. Among them, circ_DLGAP4, derived from exons 8-10 of the DLGAP4 gene, has been shown to promote mesangial cell fibrosis and progression of diabetic kidney disease in animal models, though its clinical relevance in human CKD remains unclear.

lncRNAs, such as KCNQ1OT1, also play key roles in CKD pathogenesis by modulating inflammation, fibrosis, and cell proliferation. KCNQ1OT1, located on chromosome 11p15.5, acts as a competing endogenous RNA (ceRNA) for several miRNAs and is associated with renal fibrosis and apoptosis in diabetic nephropathy. Both circ_DLGAP4 and KCNQ1OT1 are known to target miR-9, a miRNA involved in podocyte dysfunction, mitochondrial damage, and cancer-related processes. One of the validated targets of miR-9 is SOX7, a transcription factor involved in vascular development and kidney graft rejection. Despite the theoretical links among these molecules, their integrated roles in CKD pathophysiology are not fully understood.

Hemodialysis (HD) remains a cornerstone for managing advanced CKD. However, patients on maintenance HD (MHD) face high morbidity and mortality. Anemia is nearly universal in ESKD patients and significantly affects their quality of life and survival. Although erythropoiesis-stimulating agents (ESAs) have improved anemia management, a substantial proportion of patients exhibit ESA resistance, leading to increased risks and treatment challenges. ESA hypo-responsiveness-characterized by insufficient hemoglobin response despite high ESA doses-is associated with increased mortality.

Given the biological plausibility and clinical accessibility of ncRNAs in serum, their levels may aid in early detection, prognosis, and treatment stratification in CKD. This study therefore investigated the clinical relevance of serum circ_DLGAP4, KCNQ1OT1, miR-9, and their common downstream target SOX7 across different CKD stages, including patients on MHD. A particular focus was placed on exploring their association with ESA resistance in MHD patients.

Keywords
circRNAs, erythropoietin resistance, microRNAs, kidney failure
Medical subject headings
Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07037953
Study groupRoleWhat they receive
Control group60 healthy controls
non-HD group60 CKD patients not receiving hemodialysis (non-HD) group
HD Group[60 CKD Grade 5 patients undergoing MHD]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SOX7 protein assays

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

    Measured: Baseline or Day 1

  2. circ_DLGAP4 gene expression

    quantitative PCR, for circ_DLGAP4 according to the kit manufacturer's recommendations.

    Measured: Baseline at Day 1

  3. miR-9-5p gene expression

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

    Measured: Baseline at Day 1

Secondary outcomes (1)
  1. ESA hypo-responsiveness index (EHRI)

    calculated using the equation ERI = [dose of ESA (IU/ week)]/[Hb (g/dL) × body weight (kg)]

    Measured: Baseline or at Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start1 Aug 2024
  3. Primary completion1 Jan 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037953
Sponsor's protocol ID
11551
Status last verified
Apr 2026
First submitted
10 Jun 2025
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: will be available upon reasonable request

Publications

  • El Samaloty NM, Senousy MA, Sabry S, Shaker OG, Rizk NI. Integrative analysis of circ_DLGAP4, lncRNA KCNQ1OT1, and the miR-9/SOX7 interaction network in chronic kidney disease progression: a case-control study. Funct Integr Genomics. 2026 Jul 4;26(1):175. doi: 10.1007/s10142-026-01966-1.

    PubMed 42400831

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease Requiring Hemodialysis and Chronic Kidney Disease, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SOX7 protein assays (time frame: Baseline or Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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