Efficacy of desidustat in erythropoietin hyporesponsiveness among CKD patients
Phase 4
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2024/05/066867
- Lead Sponsor
- Arivazhagan S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ESRD patients on maintenance hemodialysis with anemia (hemoglobin level below 8g/dl) and receiving erythropoietin alpha and iron injection.
Exclusion Criteria
Patient with red blood cell transfusion (within 4 weeks)
History of renal transplantation
Previous or concurrent cancer
Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the hemoglobin level in hyporesponsive state <br/ ><br>The adjunct therapy will be better when compared with control treatment <br/ ><br>Can able to assess the safety of the treatmentTimepoint: Hemoglobin <br/ ><br>Hematocrit <br/ ><br>The hemoglobin and hematocrit value follow up to the baseline, after 4th week, 8th week and 12th week
- Secondary Outcome Measures
Name Time Method To reduce the number of hospital staysTimepoint: Number of hospital stay <br/ ><br>The hospital stay outcome calculated based on admission & discharge of patient (inpatient hospital days). in that days between the admission & discharge are used to identify the hospital stays