This research aims to understand better treatment approaches for managing anemia in patients with CKD, with the ultimate goal of significantly enhancing patient care and overall treatment outcomes.

Anemia Management in Chronic Kidney Disease: A Comparative Evaluation of Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) Inhibitor(s) and Erythropoiesis Stimulating Agents(ESAs) - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/05/066877

Enrollment

104

Registered

2024-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) inhibitor(s) Such as Desidustat and Roxadustat: Oral dose (100-150 mg) administered once daily for =12 weeks. Dose adjustme

Eligibility

Inclusion criteria

Inclusion criteria: A. All patients who are diagnosed with CKD with renal anemia & undergoing dialysis B. Patient should have been on dialysis for at least 3 months. C. Patients between 18-75 years will receive HIF-PHD inhibitors or ESAs

Exclusion criteria

Exclusion criteria: A. Inability to give informed consent B. Patients unable to complete the interview C. Psychiatric illness D. History of malignancy E. Any active or recent history of blood loss F. Taking part in other drug study G. Pregnant and breastfeeding women

Design outcomes

Primary

Measure	Time frame
1. Change(s) in hemoglobin from baseline to 3 rd, 6th and 12th months. 2. Changes in the iron utilization parameters, including serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, RET-He and relevant biochemistry laboratory results from baseline.Timepoint: 3rd, 6th and 12th months(1 Year).	—

Secondary

Measure	Time frame
The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) & serious adverse events, cardiovascular events, & hospitalization. The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events. To determine the differences in the treatment cost among CKD patients with anemia undergoing dialysis To assess the HRQoL of dialysis patients. To analyze the mortality. CKD-AQ (chronic kidney disease-Anemia Questionnaire) will be used for the assessment of Anemia in CKD.Timepoint: 3rd 6th & 12 months(1 year)	—

Measure

Time frame

The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) & serious adverse events, cardiovascular events, & hospitalization. The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events. To determine the differences in the treatment cost among CKD patients with anemia undergoing dialysis To assess the HRQoL of dialysis patients. To analyze the mortality. CKD-AQ (chronic kidney disease-Anemia Questionnaire) will be used for the assessment of Anemia in CKD.Timepoint: 3rd 6th & 12 months(1 year)

—

Countries

India

Contacts

Public ContactDr Anita Tahlan

Goverment Medical College and Hospital (GMCH) Chandigarh)

sanjaydcruz@gmail.com9646121556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026