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

NCT06903559 | Recruiting Phase 1

• 1 other identifier: MD.24.08.876
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Failure, Chronic; Malnutrition-Inflammation Syndrome; Anemia in End Stage Renal Disease; Cardiovascular Diseases (CVD)

Keywords

Roxadustat; Hemodialysis; Renal Anemia; Cardiovascular Diseases; Malnutrition-Inflammation-Atherosclerosis Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Left Ventricular Ejection Fraction (LVEF) at 6 Months

  Assesses the change in the percentage of blood leaving the left ventricle with each contraction, measured by transthoracic echocardiography at the beginning of the study and after 6 months of treatment. An increase indicates improvement in systolic function.

  Baseline and 6 months

Secondary Outcomes (3)

• Change from Baseline in Carotid Intima-Media Thickness (CIMT) at 6 Months

  Baseline and 6 months

• Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) Level at 6 Months

  Baseline and 6 months

• Change from Baseline in Normalized Protein Catabolic Rate (nPCR) at 6 Months

  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

Intervention Description: 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 the treatment of anemia associated with chronic kidney disease in patients on dialysis, based on hemoglobin levels.

Also known as: Evernzo

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.

Also known as: Erythropoiesis-Stimulating Agent, Iron Supplementation

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:

• 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.

You may not qualify if:

• Current pregnancy or lactation.
• Patients with pre-existing malignancy.
• Patients with psychosis or on hypnotics.
• Refuse to participate in the study.
• Known history of hematological disorders or other known causes for anemia other than CKD or dialysis.
• Patients with severe cardiovascular disease

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahliya, 35111, Egypt

RECRUITING

Related Publications (3)

• 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

• Yap DYH, McMahon LP, Hao CM, Hu N, Okada H, Suzuki Y, Kim SG, Lim SK, Vareesangthip K, Hung CC, Nangaku M; APSN HIF-PHI Recommendation Committee. Recommendations by the Asian Pacific society of nephrology (APSN) on the appropriate use of HIF-PH inhibitors. Nephrology (Carlton). 2021 Feb;26(2):105-118. doi: 10.1111/nep.13835. Epub 2020 Dec 9.

  PMID: 33222343 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; Cardiovascular Diseases

Interventions

roxadustat; Hematinics

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

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Ibrahim M Galalah, MSC

CONTACT

+201027794586; ibrahimgalalah@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 28, 2025
• First Posted: March 30, 2025
• Study Start: April 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

EG (1)