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Efficacy and safety of 2 different medicine to increase blood in kidney patients

A Randomized control study for Efficacy and safety of hypoxia inducible factor prolyl hydroxylase inhibitor(Desidustat) vs epoeitin alpha for anemia in chronic kidney disease patients not undergoing hemodialysis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077892
Enrollment
100
Registered
2024-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: N185- Chronic kidney disease, stage 5

Interventions

Intervention1: Desidustat: Desidustat 50mg 2 Tab thrice Weekly for 8 Weeks Control Intervention1: Recombinant Erythropoietin: Erythropoietin 200IU/kg SC Weekly for 8 Weeks

Sponsors

Faiz Alam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: CKD patients with Hemoglobin less than 10 CKD patients not on hemodialysis Only one drug for treating CKD patients with anemia will be studied.

Exclusion criteria

Exclusion criteria: CKD patients on hemodialysis CKD patients having hemoglobin more than 10. Primary anemia Anemia secondary to blood loss Anemia secondary to infectious disease Anemia secondary to malignancies.

Design outcomes

Primary

MeasureTime frame
1. To study the efficacy and safety of HIF prolyl hydroxylase inhibitor as compared to erythropoetin in anemia with CKD patients not on dialysis. 2. To study the increase in risk of cardiovascular events in patients on desidustat therapy compared to erythropoetin. 3 To study the change in hemoglobin in patients on desidustat therapy compared to epoetin as primary outcome.Timepoint: At Baseline and at 8 weeks

Secondary

MeasureTime frame
1. To study the change in iron related parameters ( TIBC, Hepcidin , Ferritin , serum iron, Transferrin, Tsat) . 2.Occurence of each adverse effectsTimepoint: At baseline at & at 8 weeks

Countries

India

Contacts

Public ContactFaiz Alam

Department of medicine Jawaharlal Nehru medical college aligarh

draslam8881@gmail.com9457303432

Outcome results

None listed

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