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 sites in 1 country1,000 target enrollmentStarted: January 31, 2025Last updated: February 18, 2026

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor
Enrollment: 1,000
Locations: 16
Primary Endpoint: 1. Clinical characteristics in terms of demographics and medical condition of CKD

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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 mÂ², as well as structural or functional renal abnormalities. One of the kidneysâ€™ 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 (PortolÃ©s 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.

Study Design

Study Type: Observational

Eligibility Criteria

Ages: 18.00 Year(s) to 99.00 Year(s) (—)
Sex: All

Inclusion Criteria

•Male and female subjects, aged â‰¥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.

Exclusion Criteria

•Patients with presence of uncontrolled hypertension, uncontrolled hyperparathyroidism or hypothyroidism or bleeding disorders or acute illness or chronic blood loss or hemoglobinopathy, or malignancy.