Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

this study aims to :

1. To compare the efficacy of combining low doses of Roxadustat Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase (PHD) inhibitor and iron versus standard treatment with erythropoietin-stimulating agents (ESA) in the treatment of anemia as a complication of chronic kidney disease (CKD) among dialysis-dependent patients.

2. To emphasize the safety profile of low doses of Roxadustat HIF-PHD.

3. To assess changes in the quality of life of patients with kidney disease before and after treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: Enzyme Inhibitors

Criteria

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