Assessing the differential impact of Desidustat on Reticulocyte iron indices over traditional erythropoietin in Chronic Kidney Disease (CKD) patients irrespective of Iron status
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To detect change in reticulocyte indices from baseline after a short-term treatment with Desidustat and Standard EPO therapy.
研究概览
简要总结
All patients will undergo a screening process whereby their eligibility to be included will be assessed. The study will adhere to the tenets of the Declaration of Helsinki, and ethical clearance will be taken from the Institutional Ethics Committee. All eligible patients will be subjected to sign an informed consent prior to enrolment. Only those who agree to sign the consent form will be enrolled.
Treatment naïve anaemic CKD patients will be treated as per current standards of clinical practice (KDIGO guidelines). Patients will be treated with Erythropoietin and Desidustat as per treating physician jurisdiction. Blood samples of enrolled patients will be collected at base line and on monthly basis for 2 months. Subject’s medical records will be reviewed for baseline and follow up investigations. The following investigations will be of study interest.
Patients with CKD stage 3, 4,5 (estimated Glomerular Filtration Rate < 60) with stable kidney function in past 3 months assessed by eGFR calculation with anaemia (Hb less than 10 g/dL) who have given the consent to participate in the study shall be included in the study.
1.Complete blood count
2.Kidney function test
3.Liver function test
4 Serum iron
5.Total Iron Binding Capacity
6.Ferritin
7.Reticulocyte count %
8.B12 level
9.Folate level
10.Reticulocyte haemoglobin content (CHr)
11.Reticulocyte haemoglobin equivalent (Ret-He)
12.Immature reticulocyte index
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with CKD stage 3, 4,5 (estimated Glomerular Filtration Rate below 60) with stable kidney function in past 3 months assessed by eGFR calculation with anemia (Hb less than 10 g per dL) who have given the consent to participate in the study shall be included in the study.
排除标准
- •1.Patients already on Desidustat or EPO for treatment of anaemia prior to screening 2.Patients with a history of or active bleeding 3.Post kidney allograft transplantation 4.Pregnant or expectants 5.Patients on oral or parenteral Iron therapy 6.Patients with vitamin B12, Folate deficiency 7.Patients with underlying malignancy 8.Other causes of anaemia like Hemoglobinopathies, Autoimmune haemolytic anaemia, Hypersplenism, Bone marrow disorders etc 9.Patients with HIV 10.Patients with Cirrhosis 11.ADPKD patients.
结局指标
主要结局
1.To detect change in reticulocyte indices from baseline after a short-term treatment with Desidustat and Standard EPO therapy.
时间窗: Monthly basis for 2 months
2.To confirm role of Desidustat in mobilising iron stores.
时间窗: Monthly basis for 2 months
次要结局
- To study differential impact of iron status on efficacy of Desidustat versus EPO therapy.(Monthly basis for 2 months)
研究者
Gunn Goel
All India Institute of Medical Sciences, Bathinda