CTRI/2025/01/079069 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On:
04/05/2026
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Registry
Study Design
Other
Public Title of Study
Studying the Management of Anaemia in Indian Patients with Chronic Kidney Disease, with and without Dialysis
Scientific Title of Study
A Prospective, Multicentre, Longitudinal Disease Registry of Indian Patients with Chronic Kidney
Disease, with and without Dialysis, to assess the Clinical management of Anaemia
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
DRL-IND-GGI-067-CRES/2024 version 1.0 dated 05 November 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sagar Katare
Designation
Medical Cluster Head - Ideation & CR • Medical Affairs
Affiliation
Dr. Reddys Laboratories Ltd
Address
8-2-337, Road No. 3 Banjara Hills Hyderabad, Telangana, India
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
000000
Email
sagarkatare@drreddys.com
Details of Contact Person Scientific Query
Name
Dr Sagar Katare
Designation
Medical Cluster Head - Ideation & CR • Medical Affairs
Affiliation
Dr. Reddys Laboratories Ltd
Address
8-2-337, Road No. 3 Banjara Hills Hyderabad, Telangana, India
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
000000
Email
sagarkatare@drreddys.com
Details of Contact Person Public Query
Name
Dr Sagar Katare
Designation
Medical Cluster Head - Ideation & CR • Medical Affairs
Affiliation
Dr. Reddys Laboratories Ltd
Address
8-2-337, Road No. 3 Banjara Hills Hyderabad, Telangana, India
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
000000
Email
sagarkatare@drreddys.com
Source of Monetary or Material Support
Dr. Reddys Laboratories,
8-2-337, Road No. 3
Banjara Hills
Hyderabad, Pin Code- 500034,
Telangana, India
Primary Sponsor
Name
Dr Reddys Laboratories Road No Banjara Hills Hyderabad Telangana India
Address
Dr. Reddys Laboratories,
8-2-337, Road No. 3
Banjara Hills
Hyderabad, Pin code-500034,
Telangana, India
Institutional Ethics Committee, Heritage Institute of Medical Sciences
Approved
Institutional Ethics Committee, Sarvodaya Hospital & Research Centre
Approved
Institutional Ethics Committee- Clinical Studies, Apollo Hospitals, Bhubaneswar
Approved
Institutional Ethics Committee- Clinical Studies, Apollo Hospitals, Hyderabad
Approved
Institutional Ethics Committee- Clinical Studies, Apollo Hospitals, Madurai
Approved
Institutional Ethics Committtee, Venkateshwara Hospital, Unit of Asha
Approved
Meenakshi Mission Hospital and Research Centre (MMHRC)
Approved
OrciVita Independent Ethics Committee
Approved
Orcivita Independent Ethics committee
Approved
Sterling Hospital Ethics Committee
Approved
Vision Independent Ethics Committee
Approved
Vision Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: D631||Anemia in chronic kidney disease,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Comparator Agent
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male and female subjects, aged ≥18 years.
2. 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.
3. Willing to provide inform consent to share the data.
ExclusionCriteria
Details
Patients with presence of uncontrolled hypertension, uncontrolled
hyperparathyroidism or hypothyroidism or bleeding disorders or acute illness or
chronic blood loss or hemoglobinopathy, or malignancy.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Clinical characteristics in terms of demographics and medical condition of CKD
2. Utilization patterns of various pharmacological classes including but not limited to
agents administered to stimulate erythropoiesis, iron supplementation used in
management of anaemia in CKD.
3. Assessment of response to various treatment approaches in terms of
haematological parameters and quality of life (QoL) based on KDQOL (KDQOL-SFâ„¢
v1.3)
4. Analysis of observed side effects during the management of anaemia in CKD
patients with anaemia.
Baseline, 3 months, 6 months
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="1000" Sample Size from India="1000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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 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).
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.