NCT07685223Active, not recruiting
Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients
Prospective Comparative Evaluation of the Effects of Medium Cut-Off and High-Flux Hemodialysis Membranes on Mineral and Bone Metabolism Biomarkers and Body Composition in Maintenance Hemodialysis Patients
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
This study aims to compare the effects of medium cut-off (MCO) and high-flux hemodialysis membranes on mineral and bone metabolism biomarkers in patients receiving maintenance hemodialysis. Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by disturbances in biomarkers such as fibroblast growth factor-23 (FGF-23) and sclerostin, which are associated with bone turnover, vascular calcification, and adverse clinical outcomes. This is a single-center, prospective, randomized, open-label, two-sequence, two-period crossover clinical study. Thirty adult patients receiving maintenance hemodialysis will be randomized to receive either MCO membrane treatment followed by high-flux membrane treatment or the reverse sequence, with each treatment period lasting three months. Serum FGF-23 and sclerostin levels will be measured at baseline, Month 3, and Month 6. Additional assessments will include pulse wave velocity (PWV), body composition monitoring (BCM), handgrip strength, health-related quality of life (KDQOL-36), pruritus severity (UP-Dial), and pain assessment (SF-MPQ). The study will evaluate whether MCO membranes provide additional benefits compared with conventional high-flux membranes regarding CKD-MBD-related biomarkers and patient-centered outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 24 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Gazi University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07685223
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jul 2026 to the primary completion date, 31 Jan 2027
- 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
- Major surgery within the previous 3 months.
Other illness
- Acute infection at screening or enrollment.
- Active malignancy requiring ongoing treatment.
- Terminal illness with limited life expectancy.
- Physical or cognitive impairment preventing completion of study procedures or questionnaires.
Other
- Inability or unwillingness to provide written informed consent.
Who the study is looking for
- Age 18 to 80 years.
- Receiving maintenance hemodialysis for at least 6 months.
- Clinically stable and receiving thrice-weekly hemodialysis.
- Able to comply with study procedures, questionnaires, and scheduled assessments.
- Able and willing to provide written informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.