跳至主要内容
临床试验/CTRI/2025/01/079069
CTRI/2025/01/079069招募中不适用

A Prospective, Multicentre, Longitudinal Disease Registry of Indian Patients with Chronic Kidney Disease, with and without Dialysis, to assess the Clinical management of Anaemia

Dr Reddys Laboratories Road No Banjara Hills Hyderabad Telangana India16 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年1月31日最近更新:

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

发起方
Dr Reddys Laboratories Road No Banjara Hills Hyderabad Telangana India
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Sagar Katare

Dr. Reddys Laboratories Ltd

研究点 (16)

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