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.
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
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis, Chronic Kidney Disease
- 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
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 group | Role | What they receive |
|---|---|---|
| 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] |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOX7 protein assays
Serum SOX7 protein levels determined using Human Transcription Factor SOX7 ELISA kit
Measured: Baseline or Day 1
circ_DLGAP4 gene expression
quantitative PCR, for circ_DLGAP4 according to the kit manufacturer's recommendations.
Measured: Baseline at Day 1
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)
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.
- First posted26 Jun 2025
- Study start1 Aug 2024
- Primary completion1 Jan 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Chinese University, Kasr El Aini Hospital
- Responsible party
- Sponsor
- Investigators
- Sarah Sabry, PhD, Principal investigator, Clinical pharmacy department, Faculty of pharmacy and drug technology, Egyptian Chinese University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07037953
- Acronym / sponsor ID
- 11551
- Keywords
- circRNAs, erythropoietin resistance, microRNAs, kidney failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Egyptian Chinese University, Kasr El Aini Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Subjects having < 18 years of age,
- non-compliant persons,
- smokers,
- patients with low risk of CKD (category G1),
- kidney transplant recipients,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SOX7 protein assays
Time frame: Baseline or Day 1
Serum SOX7 protein levels determined using Human Transcription Factor SOX7 ELISA kit
circ_DLGAP4 gene expression
Time frame: Baseline at Day 1
quantitative PCR, for circ_DLGAP4 according to the kit manufacturer's recommendations.
miR-9-5p gene expression
Time frame: Baseline at Day 1
quantitative PCR for miR-9-5p (MIMAT0000441) according to the manufacturer's kit recommendations.
1 secondary outcome
ESA hypo-responsiveness index (EHRI)
Time frame: Baseline or at Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 42400831El 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.
- Individual participant dataSharing planned: Undecided. will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Sabry, PhD principal investigator
Clinical pharmacy department, Faculty of pharmacy and drug technology, Egyptian Chinese University
1 site in 1 country: see every site and its status.
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.