This research aims to understand better treatment approaches for managing anemia in patients with CKD, with the ultimate goal of significantly enhancing patient care and overall treatment outcomes.
Phase 4
- Conditions
- Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
- Registration Number
- CTRI/2024/05/066877
- Lead Sponsor
- ational Institute of Pharmaceutical Education and Research, Mohali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
A. All patients who are diagnosed with CKD with renal anemia & undergoing dialysis
B. Patient should have been on dialysis for at least 3 months.
C. Patients between 18-75 years will receive HIF-PHD inhibitors or ESAs
Exclusion Criteria
A. Inability to give informed consent
B. Patients unable to complete the interview
C. Psychiatric illness
D. History of malignancy
E. Any active or recent history of blood loss
F. Taking part in other drug study
G. Pregnant and breastfeeding women
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change(s) in hemoglobin from baseline to 3 <br/ ><br>rd, 6th and 12th <br/ ><br>months. <br/ ><br>2. Changes in the iron utilization parameters, including <br/ ><br>serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, <br/ ><br>RET-He and relevant biochemistry laboratory results from <br/ ><br>baseline.Timepoint: 3rd, 6th and 12th <br/ ><br>months(1 Year).
- Secondary Outcome Measures
Name Time Method The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) & serious adverse events, cardiovascular events, & hospitalization. The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events. <br/ ><br> <br/ ><br>To determine the differences in the treatment cost among CKD patients with anemia undergoing dialysis <br/ ><br> <br/ ><br>To assess the HRQoL of dialysis patients. <br/ ><br> <br/ ><br>To analyze the mortality. <br/ ><br> <br/ ><br>CKD-AQ (chronic kidney disease-Anemia Questionnaire) will be used for the assessment of Anemia in CKD.Timepoint: 3rd 6th & 12 months(1 year)