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NCT06917950RecruitingPhase 1/2

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Effect of Roxadustat on Bone and Neuropsychiatric Aspects in End Stage Kidney Disease Patients on Hemodialysis

Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

People with severe kidney failure who need regular hemodialysis treatment often experience several health problems. These include anemia (low red blood cell count), issues with their bone health (sometimes called mineral and bone disease), and mental health challenges like depression and anxiety. They may also have problems with their nerves and muscles. Roxadustat is a newer medicine, taken as a pill, used to treat anemia caused by kidney disease. It works differently than the standard injectable medications often used. This study aims to investigate if Roxadustat has effects beyond treating anemia in hemodialysis patients. Specifically, researchers want to see if taking Roxadustat affects patients' bone health (measured by bone density scans and blood tests) and their psychological well-being (looking at symptoms of depression and anxiety using questionnaires). The study will also use ultrasound to look at potential changes in nerves and muscles. The study will enroll 46 patients on hemodialysis. Patients will be randomly assigned (like flipping a coin) into two groups. One group (23 patients) will receive Roxadustat three times a week, while the other group (23 patients) will continue receiving their usual conventional treatment for anemia. All patients will be followed for 6 months. During this time, they will have regular blood tests, bone density scans (using a technique called QCT), nerve and muscle ultrasound examinations, and will complete questionnaires about their mood. Researchers will compare the results between the two groups to understand the effects of Roxadustat on bone, mood, anxiety, and neuromuscular aspects in patients undergoing hemodialysis

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
46 (estimated)
First submitted
27 Mar 2025
Start date
15 Apr 2025
Primary completion date
15 Oct 2025
Lead sponsor
Mansoura University
NCT number
NCT06917950

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.

Prior treatment

  • Taking medications that may significantly affect or interact with bone metabolism such as osteo-anabolics or bone resorptives during the last 6 months.

Other illness

  • Patients with pre-existing malignancy.
  • Known history of hematological disorders or other causes of anemia other than CKD.

Other

  • Current pregnancy or lactation.
  • patients with psychosis.

Who the study is looking for

  • The age of the 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. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Urology and Nephrology Center, Mansoura University
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Al MansurahEgyptRecruiting

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