Health Condition 1: R718- Other abnormality of red blood cells
Conditions
Interventions
Intervention1: NIL: Intervention and comparator: NIL
Sponsors
National Institute of Pharmaceutical Education and Research, Mohali
Eligibility
Inclusion criteria
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
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 studies G. Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change(s) in hemoglobin from baseline to 3 rd, 6th and 12th months. 2. Changes in the iron utilization parameters, including serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, RET-He and relevant biochemistry laboratory results from baseline. Timepoint: 1. Change(s) in hemoglobin from baseline to 3 rd, 6th and 12th months. 2. Changes in the iron utilization parameters, including serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, RET-He and relevant biochemistry laboratory results from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) and serious adverse events, cardiovascular events, and hospitalization. The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events. To determine the differences in the treatment cost among CKD patients with anemia undergoing dialysis To assess the HRQoL of dialysis CKD patients CKD-AQ (chronic kidney disease-Anemia Questionnaire) will be used for the assessment of Anemia in CKDTimepoint: 1 Year | — |
Countries
India
Contacts
Public ContactDr. Sanjay Dcruz
Goverment Medical College and Hospital (GMCH) Chandigarh)
Outcome results
None listed