Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06917950

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Led by Mansoura University · Updated on 2025-05-11

46

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Willingness to sign informed consent
  • End stage kidney disease patients on chronic hemodialysis for more than 3 months
Not Eligible

You will not qualify if you...

  • Current pregnancy or breastfeeding
  • Pre-existing cancer
  • Diagnosis of psychosis
  • History of blood disorders or anemia causes other than chronic kidney disease
  • Use of medications affecting bone metabolism such as osteo-anabolics or bone resorptives within the last 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahliya, Egypt, 35111

Actively Recruiting

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Research Team

M

Mostafa I Alaskary, M.Sc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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