CompletedNot Applicable

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

Egypt180 participantsStarted 2024-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SOX7 protein assays

Timeframe: Baseline or Day 1

circ_DLGAP4 gene expression

Timeframe: Baseline at Day 1

miR-9-5p gene expression

Timeframe: Baseline at Day 1

Trial details

NCT IDNCT07037953

SponsorAin Shams University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Chronic Kidney Disease Requiring Hemodialysis trials