A Prospective, Multicentre, Longitudinal Disease Registry of Indian Patients with Chronic Kidney Disease, with and without Dialysis, to assess the Clinical management of Anaemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 16
- 主要终点
- 1. Clinical characteristics in terms of demographics and medical condition of CKD
研究概览
简要总结
Chronic kidney disease (CKD) is a significant public health issue worldwide, characterized by a reduction in estimated glomerular filtration rate (eGFR) to less than 60 ml/min/1.73 m², as well as structural or functional renal abnormalities. One of the kidneys’ essential functions is the production of erythropoietin, a signaling molecule that stimulates red blood cell production in response to decreased oxygen levels in the blood. Thus, haemoglobin (Hb) levels are typically lower in CKD patients compared to the general population. (Sofue T et al., 2024).
Anaemia is a common and serious complication of chronic kidney disease (CKD), affecting a significant proportion of patients as CKD progresses. It is associated with increased morbidity, reduced quality of life, and higher mortality rates (Portolés et al., 2021). The primary causes of Anaemia in CKD include reduced erythropoietin production, iron deficiency, and chronic inflammation (Hain et al., 2023; Shaikh et al., 2024).
Management of anaemia in CKD varies in India based on whether the patient is on dialysis. According to the KDIGO guidelines, the use of erythropoiesis-stimulating agents (ESAs) is recommended for patients with anemia associated with chronic kidney disease (CKD). Furthermore, the guidelines emphasize the importance of iron supplementation to enhance the efficacy of ESAs, particularly in cases of iron deficiency with careful considerations. (Babitt JL et al., 2012).
For non-dialysis-dependent CKD patients, treatment primarily involves oral or intravenous iron supplements and erythropoiesis-stimulating agents (ESAs) such as darbepoetin alfa, or epoetin alfa. (Shaikh et al., 2024; Biju et al., 2024).
This prospective, multicenter longitudinal disease registry aims to collect comprehensive data on the clinical characteristics, outcomes and usage trends associated with various treatment modalities for managing Anaemia in CKD patients. The registry will provide valuable insights to guide clinical decision-making and improve the management of Anaemia in CKD across India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Male and female subjects, aged ≥18 years.
- •CKD patients (as defined in KDIGO guidelines) with Hb level less than 10g/dl (as per the latest available test report), with/without the need of dialysis and who have newly commenced therapy for anemia, including at least one agent each for stimulating erythropoiesis and iron supplementation, with or without any other agents.
- •Willing to provide inform consent to share the data.
排除标准
- •Patients with presence of uncontrolled hypertension, uncontrolled hyperparathyroidism or hypothyroidism or bleeding disorders or acute illness or chronic blood loss or hemoglobinopathy, or malignancy.
结局指标
主要结局
1. Clinical characteristics in terms of demographics and medical condition of CKD
时间窗: Baseline, 3 months, 6 months
2. Utilization patterns of various pharmacological classes including but not limited to
时间窗: Baseline, 3 months, 6 months
agents administered to stimulate erythropoiesis, iron supplementation used in
时间窗: Baseline, 3 months, 6 months
management of anaemia in CKD.
时间窗: Baseline, 3 months, 6 months
3. Assessment of response to various treatment approaches in terms of
时间窗: Baseline, 3 months, 6 months
haematological parameters and quality of life (QoL) based on KDQOL (KDQOL-SFâ„¢
时间窗: Baseline, 3 months, 6 months
v1.3)
时间窗: Baseline, 3 months, 6 months
4. Analysis of observed side effects during the management of anaemia in CKD
时间窗: Baseline, 3 months, 6 months
patients with anaemia.
时间窗: Baseline, 3 months, 6 months
次要结局
- NA(NA)
研究者
Dr Sagar Katare
Dr. Reddys Laboratories Ltd
