A COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF PROLYL HYDROXYLASE INHIBITOR DESIDUSTAT AND DARBEPOETIN ALFA IN CHRONIC KIDNEY DISEASE PATIENTS WITH ANAEMIA IN A TERTIARY CARE CENTER.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
It is a prospective, randomized, open-label comparative study evaluating the efficacy and safety of Desidustat versus Darbepoetin alfa in patients with chronic kidney disease (CKD)–associated anemia at a tertiary care center.
To compare both treatments in terms of improvement and maintenance of hemoglobin levels, iron indices, and red blood cell parameters, while also assessing safety, tolerability, inflammatory markers (CRP, ESR), and oxidative stress biomarkers (MDA, MPO).
A total of 80 non-dialysis CKD patients (stage 2–4) aged 18–75 years with moderate to severe anemia will be randomized equally into two groups: one receiving oral Desidustat and the other subcutaneous Darbepoetin alfa, over a 12-week treatment period. Data will be statistically analyzed using SPSS to determine efficacy and safety outcomes.
The study is expected to provide evidence on whether Desidustat, a newer oral HIF-PH inhibitor, can serve as an effective and safe alternative to conventional erythropoiesis-stimulating agents in managing anemia in CKD patients.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All stable outpatients with chronic kidney disease (CKD) stage 2–4 , not on dialysis, aged between 18-75 years ,with moderate anemia (8-10g/dl) and severe anemia (6.5-7.9 g/dl).
- •2.Willing to give written informed consent.
排除标准
- •1.Recent use of erythropoiesis -stimulation agents (ESAs) 2.Recent blood transfusion within 8 weeks.
- •History of any active or recent malignancy within 5 years.
- •4.Pregnant or lactating.
- •5.History of thrombotic disorders, thromboembolism in the past.
- •6.Patients with iron deficiency, B12 deficiency have been ruled out.
研究者
Dr Nithya T
Department of Pharmacology, A C S Medical College and Hospital