A comparative analysis of erythropoietin alpha and erythropoietin alpha with desidustat in the management of anemia during hemodialysis a randomized study
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
Kowsigan M
PSG college of pharmacy
