EFFICACY AND SAFETY OF DESIDUSTAT IN CHILDREN WITH ANEMIA AND CHRONIC KIDNEY DISEASE
Not Applicable
- Conditions
- Health Condition 1: D631- Anemia in chronic kidney disease
- Registration Number
- CTRI/2022/09/045877
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age: 10 to 18 years
Chronic kidney disease stage 3 to stage 5
Anemia based on age and gender-specific values (KDIGO 2012)
Iron-replete state (T sat >20% and Ferritin >100 ng/mL)
Normal B12 and folate levels
Written informed consent
Exclusion Criteria
1. Anemia due to a cause other than CKD
2. CKD on dialysis at enrolment
3. Recent PRBC transfusion ( <4 weeks)
4. Hyperparathyroidism (iPTH >700 pg/mL)
5. Children on ESA with Hb <9 g/dL
6. Stage 2 hypertension even on anti-hypertensive medications
7. Hypersensitivity to desidustat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method