Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients (ROXA-HD-MIA)

May 8, 2025 updated by: Ibrahim Mohammed Galalah, Mansoura University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Renal anemia is a frequent and significant complication in patients with end-stage kidney disease undergoing hemodialysis, affecting over 90% of this population. Anemia adversely impacts quality of life and is associated with increased cardiovascular risk, hospitalization rates, and mortality. These patients also commonly experience Malnutrition-Inflammation-Atherosclerosis (MIA) syndrome and have significantly elevated cardiovascular mortality compared to the general population. While Erythropoiesis-stimulating agents (ESAs) are a mainstay of therapy, concerns exist regarding potential adverse events, particularly with high doses, highlighting the need for alternative or complementary strategies.

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that represents a newer class of agents for treating renal anemia. By inhibiting HIF degradation, Roxadustat mimics a hypoxic state, leading to enhanced endogenous erythropoietin synthesis and improved iron metabolism pathways. While its efficacy in managing anemia is established, its potential effects on the interconnected issues of cardiovascular disease (CVD) and MIA syndrome in the hemodialysis population remain poorly understood and require further investigation.

This study hypothesizes that Roxadustat, compared to conventional anemia management, may offer benefits beyond hemoglobin correction, potentially improving cardiovascular parameters and ameliorating aspects of the MIA syndrome in hemodialysis patients.

This is a randomized, open-label, parallel-group, controlled clinical trial conducted at the Urology and Nephrology center, Mansoura University. Eligible chronic hemodialysis patients will be randomized 1:1 to receive either Roxadustat (intervention group) or continue conventional anemia therapy (control group) for a duration of 6 months. Conventional therapy typically includes ESAs and iron supplementation as per standard clinical practice.

Key assessments will include evaluation of cardiovascular status (utilizing echocardiography for structural and functional assessment, and Doppler ultrasound for carotid intima-media thickness), markers relevant to MIA syndrome (including anthropometric measurements, inflammatory markers like high-sensitivity C-reactive protein (hs-CRP) and Endothelin-1, nutritional markers, lipid profiles, and measures like normalized protein catabolic rate (nPCR)), and parameters related to anemia management (hemoglobin, iron indices). Data will be collected at baseline and at the end of the 6-month study period. Safety monitoring will occur throughout the trial. Statistical analysis will compare changes between the two groups using appropriate methods for quantitative and qualitative data.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahliya
      • Mansoura, Dakahliya, Egypt, 35111
        • Recruiting
        • Urology and Nephrology center, Mansoura University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roxadustat Group
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
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.
Other Names:
  • Evernzo
Active Comparator: Conventional Treatment Group
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
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.
Other Names:
  • Erythropoiesis-Stimulating Agent
  • Iron Supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Left Ventricular Ejection Fraction (LVEF) at 6 Months
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Carotid Intima-Media Thickness (CIMT) at 6 Months
Time Frame: Baseline and 6 months
Assesses the change in the thickness of the inner layers of the carotid artery wall, a marker of atherosclerosis. Measured by Doppler ultrasound of the carotid artery at the beginning of the study and after 6 months of treatment. A decrease or smaller increase indicates less progression of atherosclerosis.
Baseline and 6 months
Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) Level at 6 Months
Time Frame: Baseline and 6 months
Assesses the change in a marker of systemic inflammation. Measured via laboratory blood test at the beginning of the study and after 6 months of treatment. A decrease indicates reduced inflammation.
Baseline and 6 months
Change from Baseline in Normalized Protein Catabolic Rate (nPCR) at 6 Months
Time Frame: Baseline and 6 months
Assesses the change in protein catabolism, reflecting nutritional status and protein intake adequacy in dialysis patients. Calculated based on urea kinetics (typically from pre- and post-dialysis BUN and dialysis parameters) at the beginning of the study and after 6 months. An increase may indicate improved nutritional status (within appropriate ranges).
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.24.08.876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A final decision regarding the sharing of individual participant data (IPD) has not yet been made. Factors such as institutional policies, data privacy regulations, resource availability for data de-identification and sharing, and specific requests from qualified researchers will be considered post-study completion before determining if and how IPD might be shared. Any potential sharing would be subject to appropriate ethical and institutional approvals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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