New combo could ease anemia for kidney patients on dialysis
NCT ID NCT06115421
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a low dose of the drug Roxadustat, combined with iron, can safely and effectively treat anemia in people with kidney disease who are on dialysis. The trial involved 72 adults and compared the combination to standard treatment with erythropoietin-stimulating agents. Researchers measured changes in hemoglobin levels, iron levels, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Roxadustat (a drug that helps the body produce more red blood cells) plus iron
- What this could lead to
- If successful, this could offer a safer, lower-dose option to manage anemia in dialysis patients, potentially reducing side effects and improving quality of life.
- What could go wrong
- This is a small, completed Phase 4 trial with only 72 participants. Results may not apply to all patients, and the drug may still cause side effects or not work as well as standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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72 people
The number who actually took part.
- Started
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May 2023
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 1. Ages \>18. 2. End Stage Renal Disease (ESRD) on Incident Dialysis (ID), defined as dialysis ≥2 weeks but ≤4 months or stable dialysis (dialysis dependent DD) defined as dialysis for ≥ 4 months \&having hemodialysis access. 3\. Hb ≤10.5 g/dl during the screening period. 4. Erythropoiesis-stimulating agents (ESAs) naïve patients, ESAs resistant patients, or patients who didn't receive any ESA treatment within 4-6 weeks Exclusion Criteria: * 1\. Age \<18 year or \>80 year 2. Known hypersensitivity to active substances, peanuts, soya, or any of the drug excipients. 3\. History of hereditary problems galactose intolerance 4. Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be reevaluated once BP is controlled. 5\. Congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV 6. Acute coronary syndrome (ACS), a thrombotic/thromboembolic event (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE)), stroke, or seizure, within 12 weeks prior to randomization. 7\. Elective coronary revascularization or elective surgery that is expected to lead to significant blood loss. 8\. Hematologic diseases such as thalassemia, sickle cell anemia, active inflammatory bowel disease, active or chronic gastrointestinal bleeding, significant blood loss, or any other known causes for anemia other than CKD. 9\. Red blood cell transfusion within 6 weeks prior to the first screening visit. 10\. More than one dose of IV iron was received within 12 weeks prior to recruiting. 11\. History of uncontrolled chronic, severe, fulminant, autoimmune, or end-stage liver disease with Aspartate aminotransferase( AST), alanine aminotransferase (ALT) \> 3 × upper limit normal (ULN), or total bilirubin \> 1.5 × ULN. 12. Any clinically significant inflammatory disorders other than CKD, as any evidence of an active underlying infection, rheumatoid arthritis, systemic lupus, or cancer. 13\. Known and untreated retinal vein occlusion or proliferative diabetic retinopathy, macular degeneration, diabetic macular edema. 14\. Prior organ transplant or a scheduled organ transplantation date. 15. Planning for pregnancy, pregnant, or breastfeeding female patients
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alexandria University
Alexandria, Egypt