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Clinical Trials/CTRI/2024/05/066867
CTRI/2024/05/066867Not yet recruitingPhase 4

A comparative analysis of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis a randomized study

Arivazhagan S1 site in 1 country44 target enrollmentStarted: May 15, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
44
Locations
1
Primary Endpoint
Improvement in the hemoglobin level in hyporesponsive state

Study Overview

Brief Summary

Anemia is a consequence of chronic kidney and is linked to morbidity and mortality in both patients with and without dialysis-dependent CKD. Erythropoietin, including rHuEPO, demonstrate efficacy in elevating hemoglobin levels and decreasing the requirement for blood transfusions in individuals with CKD, consequently enhancing their quality of life. Approximately 5–10% of patients receiving ESAs experiences hyporesponsiveness that leads to higher cardiovascular morbidity and all-cause mortality in a significant number of individuals with CKD. Desidustat is a new molecule, hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anemia associated with CKD. Desidustat inhibits prolyl hydroxylase domain enzymes, resulting in the stabilization of hypoxia-inducible factor which stimulates erythropoietin production and erythropoiesis. Aim: To compare the efficacy of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis. Method: The patients were randomized into treatment and control group using the block randomization technique. The control group received erythropoietin alpha whereas treatment group received desidustat with erythropoietin alpha. The level of hemoglobin and hematocrit were measured during baseline and follow ups for both treatment and control group. Expected outcomeImprovement in the hemoglobin level in hyporesponsive state, The adjunct therapy will be better when compared with control treatment and Can able to assess the safety of the treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ESRD patients on maintenance hemodialysis with anemia (hemoglobin level below 8g/dl) and receiving erythropoietin alpha and iron injection.

Exclusion Criteria

  • Patient with red blood cell transfusion (within 4 weeks) History of renal transplantation Previous or concurrent cancer Pregnancy and lactation.

Outcomes

Primary Outcomes

Improvement in the hemoglobin level in hyporesponsive state

Time Frame: Hemoglobin | Hematocrit | The hemoglobin and hematocrit value follow up to the baseline, after 4th week, 8th week and 12th week

The adjunct therapy will be better when compared with control treatment

Time Frame: Hemoglobin | Hematocrit | The hemoglobin and hematocrit value follow up to the baseline, after 4th week, 8th week and 12th week

Can able to assess the safety of the treatment

Time Frame: Hemoglobin | Hematocrit | The hemoglobin and hematocrit value follow up to the baseline, after 4th week, 8th week and 12th week

Secondary Outcomes

  • To reduce the number of hospital stays(Number of hospital stay)

Investigators

Sponsor
Arivazhagan S
Sponsor Class
Other []
Responsible Party
Principal Investigator
Principal Investigator

Kowsigan M

PSG college of pharmacy

Study Sites (1)

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