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

Last updated: January 31, 2024
Sponsor: Alexandria University
Overall Status: Active - Recruiting

Phase

4

Condition

Anemia

Treatment

Roxadustat

Clinical Study ID

NCT06115421
0201793
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Ages >18. 2. End Stage Renal Disease (ESRD) on Incident Dialysis (ID), defined asdialysis ≥2 weeks but ≤4 months or stable dialysis (dialysis dependent DD) defined asdialysis for ≥ 4 months &having hemodialysis access.
  1. 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 treatmentwithin 4-6 weeks

Exclusion

Exclusion Criteria:

    1. Age <18 year or >80 year 2. Known hypersensitivity to active substances, peanuts,soya, or any of the drug excipients.
  1. History of hereditary problems galactose intolerance 4. Systolic BP ≥160 mmHg ordiastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may bereevaluated once BP is controlled.
  2. Congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV
  3. Acute coronary syndrome (ACS), a thrombotic/thromboembolic event (eg, deep veinthrombosis (DVT) or pulmonary embolism (PE)), stroke, or seizure, within 12 weeksprior to randomization.
  4. Elective coronary revascularization or elective surgery that is expected to lead tosignificant blood loss.
  5. Hematologic diseases such as thalassemia, sickle cell anemia, active inflammatorybowel disease, active or chronic gastrointestinal bleeding, significant blood loss, orany other known causes for anemia other than CKD.
  6. Red blood cell transfusion within 6 weeks prior to the first screening visit.
  7. More than one dose of IV iron was received within 12 weeks prior to recruiting.
  8. History of uncontrolled chronic, severe, fulminant, autoimmune, or end-stage liverdisease with Aspartate aminotransferase( AST), alanine aminotransferase (ALT) > 3 ×upper limit normal (ULN), or total bilirubin > 1.5 × ULN. 12. Any clinicallysignificant inflammatory disorders other than CKD, as any evidence of an activeunderlying infection, rheumatoid arthritis, systemic lupus, or cancer.
  9. Known and untreated retinal vein occlusion or proliferative diabetic retinopathy,macular degeneration, diabetic macular edema.
  10. Prior organ transplant or a scheduled organ transplantation date. 15. Planning forpregnancy, pregnant, or breastfeeding female patients

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Roxadustat
Phase: 4
Study Start date:
May 24, 2023
Estimated Completion Date:
May 31, 2024

Study Description

1- The Ethics Committee of Alexandria University approved conducting the research in April 2023.

  1. Informed consent will be obtained from all patients to participate in the trial after a thorough explanation of the nature of the study 3. Dialysis-dependent CKD patients with anemia will be recruited from Alexandria University Hospital &/or private hospitals (if any).

  2. Study design: two-arm open-label non randomized active control study 5. Sample size was calculated using G*Power 3, a minimal total hypothesized sample size of 72 eligible adult Dialysis dependent CKD patients (DD -CKD) with anemia [ 36 per group] is needed; taking into consideration 95% confidence level, the effect size of 0.6. and 80% power using a t-test.

  3. Three phases will comprise the trial: a screening phase that lasts from 2-4 weeks, a therapy phase that lasts for up to 12 weeks, and a follow-up phase that lasts 2-4 weeks. After obtaining informed consent, during visit 1, we will check the inclusion and exclusion criteria At each visit, the patient's well-being and the occurrence of any Drug-Related Adverse effects (DRAs) will be monitored accurately.

  4. The Arabic-translated reliable and valid version of the Kidney Disease Quality of Life questionnaire (KDQOL-36) for patients with CKD will be completed with patients during the interview at the baseline and after fulfilling the whole study period 8. The collected data will be subjected to statistical analysis by the use of suitable techniques to achieve the objectives of the study

Connect with a study center

  • Alexandria University

    Alexandria,
    Egypt

    Active - Recruiting

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