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临床试验/CTRI/2024/05/066867
CTRI/2024/05/066867尚未招募4 期

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

Arivazhagan S1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Improvement in the hemoglobin level in hyporesponsive state

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

Improvement in the hemoglobin level in hyporesponsive state

时间窗: 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

时间窗: 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

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

次要结局

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

研究者

发起方
Arivazhagan S
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Kowsigan M

PSG college of pharmacy

研究点 (1)

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