Health Condition 1: D631- Anemia in chronic kidney disease
Conditions
Interventions
Intervention1: DESIDUSTAT: DESIDUSTAT oral tablets thrice weekly at 2-2.5 mg/kg/dose thrice weekly for a total of 12 weeks
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Anemia due to a cause other than CKD 2. CKD on dialysis at enrolment 3. Recent PRBC transfusion ( 4. Hyperparathyroidism (iPTH >700 pg/mL) 5. Children on ESA with Hb 6. Stage 2 hypertension even on anti-hypertensive medications 7. Hypersensitivity to desidustat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In patients, 10-18 years old, with anemia due to chronic kidney disease administered desidustat (Oxemia®) orally thrice weekly for 12 weeks, to determine absolute increase in hemoglobin levels from baseline after 12 weeksTimepoint: Baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of children achieving specific target hemoglobin levels (11-12 g/dL)Timepoint: Baseline and 12 weeks;Percentage increase in hemoglobin levelTimepoint: Baseline and 12 weeks;Change from baseline to 12 weeks in iron profile (serum iron, serum transferrin, total iron-binding capacity, ferritin, transferrin saturation)Timepoint: Baseline and 12 weeks;Change from baseline to 12 weeks in hepcidin and low-density lipoproteinTimepoint: Baseline and 12 weeks;Proportion of children with treatment emergent adverse events/severe adverse eventsTimepoint: Anytime during the study period | — |
Countries
India
Contacts
Public ContactRahul Sharma
AIIMS, New Delhi
Outcome results
None listed