Status:
UNKNOWN
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
Lead Sponsor:
Alexandria University
Conditions:
Anemia in Dialysis-dependent CKD Patients
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 erythrop...
Detailed Description
1- The Ethics Committee of Alexandria University approved conducting the research in April 2023. 2\. Informed consent will be obtained from all patients to participate in the trial after a thorough e...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06115421
Start Date
May 24 2023
End Date
May 1 2024
Last Update
February 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alexandria University
Alexandria, Egypt