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临床试验/CTRI/2024/05/066877
CTRI/2024/05/066877招募中Unknown

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)

National Institute of Pharmaceutical Education and Research, Mohali1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年5月14日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
104
试验地点
1
主要终点
1. Change(s) in hemoglobin from baseline to 3

研究概览

简要总结

Chronic Kidney Disease (CKD) is a prevalent condition worldwide, with a significant number of patients progressing to end-stage renal disease (ESRD) and requiring dialysis. These patients often have anemia, which is a common complication of CKD. This is associated with poorer quality of life, increased healthcare costs, and a higher risk of mortality.

Traditionally, erythropoiesis-stimulating agents (ESAs) have been the standard of care for managing anemia in CKD patients undergoing dialysis. However, recent research has explored the potential of Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) inhibitors as an alternative option.

The potential benefits of HIF-PHD inhibitors include- they are orally-administered, effectively raise or preserve hemoglobin levels, and induce an increase in endogenous EPO production within the desired physiological range. They exert control over iron metabolism, particularly by reducing hepcidin levels, enhance iron absorption, and remain unaffected by inflammation. Additionally, they may contribute to reducing cholesterol levels and have demonstrated potential cardioprotective effects with decreased inflammation.

This study aims to evaluate the effectiveness and safety of HIF-PHD inhibitor(s) against the standard treatment in CKD patients with anemia. Further, the estimation of safety, cost of treatment and quality of life of anemic chronic kidney disease patients undergoing dialysis are also proposed.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

1. Change(s) in hemoglobin from baseline to 3

时间窗: 3rd, 6th and 12th | months(1 Year).

rd, 6th and 12th

时间窗: 3rd, 6th and 12th | months(1 Year).

months.

时间窗: 3rd, 6th and 12th | months(1 Year).

2. Changes in the iron utilization parameters, including

时间窗: 3rd, 6th and 12th | months(1 Year).

serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin,

时间窗: 3rd, 6th and 12th | months(1 Year).

RET-He and relevant biochemistry laboratory results from

时间窗: 3rd, 6th and 12th | months(1 Year).

baseline.

时间窗: 3rd, 6th and 12th | months(1 Year).

次要结局

  • 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.

研究者

发起方
National Institute of Pharmaceutical Education and Research, Mohali
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Pramil Tiwari

National Institute of Pharmaceutical Education and Research (NIPER) Mohali

研究点 (1)

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