Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

NCT06917950 | Recruiting Phase 1

• 1 other identifier: MD.24.08.877
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Kidney Failure,Chronic; Anemia in End Stage Renal Disease; Depression Anxiety Disorder

Keywords

Roxadustat; Hemodialysis; Renal Anemia; Bone Mineral Density (BMD); Quantitative Computed Tomography (QCT); Neuropsychiatric; Musculoskeletal Ultrasound (MSK-US)

Outcome Measures

Primary Outcomes (1)

• Change in Lumbar Spine Bone Mineral Density

  Change from baseline in cortical and trabecular bone mineral density (BMD) and volume assessed at the lumbar spine using Quantitative Computed Tomography (QCT). Measured typically in mg/cm³.

  Baseline and 6 months

Secondary Outcomes (3)

• Change in Peripheral Nerve Morphology via Ultrasound

  Baseline and 6 months

• Change in Muscle Morphology via Ultrasound

  Baseline and 6 months

• Change in Handgrip Strength

  Baseline and 6 months

Study Arms (2)

Roxadustat Group

EXPERIMENTAL

Participants randomized to this arm will receive oral Roxadustat (Evernzo) three times per week according to standard dosing guidelines for managing anemia in hemodialysis patients. Participants will continue standard care for other conditions but will discontinue other erythropoiesis-stimulating agents (ESAs). Dosing may be adjusted based on hemoglobin response as per protocol and product labeling.

Drug: Roxadustat

Conventional Treatment Group

ACTIVE COMPARATOR

Participants randomized to this arm will continue receiving their conventional management for renal anemia, typically including erythropoiesis-stimulating agents (ESAs) and/or intravenous iron, as determined by standard clinical practice at the study site. Participants will receive standard care for all other conditions.

Drug: Conventional Anemia Management

Interventions

Roxadustat DRUG

Oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Administered orally three times per week. Dosage will be initiated and adjusted according to prescribing guidelines for treating anemia associated with chronic kidney disease in patients on dialysis based on hemoglobin levels.

Roxadustat Group

Conventional Anemia Management DRUG

Standard of care treatment for renal anemia, typically involving administration of erythropoiesis-stimulating agents (ESAs, e.g., epoetin, darbepoetin) and/or intravenous iron supplementation. Dosing and specific agents used are per standard clinical practice at the study site and adjusted based on hemoglobin levels and iron status according to prevailing guidelines.

Conventional Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current pregnancy or lactation.
• Patients with pre-existing malignancy.
• patients with psychosis.
• Known history of hematological disorders or other causes of anemia other than CKD.
• Taking medications that may significantly affect or interact with bone metabolism such as osteo-anabolics or bone resorptives during the last 6 months.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahliya, 35111, Egypt

RECRUITING

Related Publications (3)

• Liu Y, Wang J, Chen D, Kam WR, Sullivan DA. The Role of Hypoxia-Inducible Factor 1alpha in the Regulation of Human Meibomian Gland Epithelial Cells. Invest Ophthalmol Vis Sci. 2020 Mar 9;61(3):1. doi: 10.1167/iovs.61.3.1.

  PMID: 32150252 BACKGROUND

• Sanghani NS, Haase VH. Hypoxia-Inducible Factor Activators in Renal Anemia: Current Clinical Experience. Adv Chronic Kidney Dis. 2019 Jul;26(4):253-266. doi: 10.1053/j.ackd.2019.04.004.

  PMID: 31477256 BACKGROUND

• Zhou Q, Mao M, Li J, Deng F. The efficacy and safety of roxadustat for anemia in patients with dialysis-dependent chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2023 Dec;45(1):2195011. doi: 10.1080/0886022X.2023.2195011.

  PMID: 37489561 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mostafa I Alaskary, M.Sc

CONTACT

+201017178892; drmostafa2110@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: April 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

EG (1)