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NCT06903559RecruitingPhase 1/2

Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients

Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Patients with kidney failure who require hemodialysis often suffer from anemia (low red blood cell count), heart and blood vessel problems, and a condition involving poor nutrition, inflammation, and hardening of the arteries (called MIA syndrome). Standard treatments for anemia often involve injections and iron supplements. This study aims to see if a newer oral medication, Roxadustat, works better than these standard treatments not only for anemia but also for improving cardiovascular health and the MIA syndrome. Participants in the study will be randomly assigned (like by chance) to one of two groups. One group will receive Roxadustat, while the other group will continue with their conventional anemia treatment. Researchers will compare the effects on heart function, markers of nutrition and inflammation, and anemia levels in both groups over a 6-month period.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
46 (estimated)
First submitted
28 Mar 2025
Start date
15 Apr 2025
Primary completion date
15 Oct 2025
Lead sponsor
Mansoura University
NCT number
NCT06903559

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 46
  • From 15 Apr 2025 to the primary completion date, 15 Oct 2025
  • 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.

Other illness

  • Patients with pre-existing malignancy.
  • Known history of hematological disorders or other known causes for anemia other than CKD or dialysis.
  • Patients with severe cardiovascular disease

Other

  • Current pregnancy or lactation.
  • Patients with psychosis or on hypnotics.
  • Refuse to participate in the study.

Who the study is looking for

  • Age of patient is more than 18.
  • Patients who are willing to sign informed consent.
  • Patients with ESKD on chronic hemodialysis for more than 3 months.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Urology and Nephrology Center, Mansoura University
Coordinator of this site? Confirm its status
Al MansurahEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.