Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Desidustat: Duration of Therapy: 6 Months
Desidustat (Oxemia™) is an orally bioavailable, small molecule, hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor developed by Zy
Sponsors
Saajid Hameed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations was to be 7.0-10.0 g/dL (both inclusive) before the enrollment. 2. Ability to understand and give informed consent for participation. 3. Male or female patients diagnosed with CKD (stage III to IV), defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula. 4. Male or female, 18 to 80 years of age. 5. Body weight > 40 kg. 6. Subjects not on dialysis and not expected to start dialysis during the study period. 7. Serum ferritin =100 ng/mL and/or TSAT >20%. 8. No iron, folate or Vitamin B12 deficiency.
Exclusion criteria
Exclusion criteria: Prior chronic hemodialysis or chronic peritoneal dialysis treatment. Intravenous iron within 14 days prior to enrollment. Prior exposure of rhEPO analogues less than 04 weeks. Red blood cell transfusion within 8 weeks prior to enrollment. History of previous or concurrent cancer. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus infection. Active infection prior to enrollment. History of renal transplant. Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing. Presence or a history of bleeding disorders or clinical conditions that could increase risk of life-threatening bleeding. Pregnant and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobinTimepoint: 0 to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood cells countTimepoint: 0 to 6 months;Change in erythrocyte sedimentation rate (ESR) and C- Reactive Protein (CRP)Timepoint: 0 to 6 months;Change in Packed Cell Volume (PCV)Timepoint: 0 to 6 months;Change in potassium levelsTimepoint: 0 to 6 months;Change in the lipid, and lipoprotein profileTimepoint: 0 to 6 months;Change in transferrin saturationTimepoint: 0 to 6 months;Number (%) of subjects on rescue therapyTimepoint: 0 to 6 months;Number of subjects with hemoglobin response defined as target level of 10–12 g/dL and post-treatment increase of 1 g/dL or more by Week 24Timepoint: 0 to 6 months;Percentage of time spent in the target hemoglobin range (10-12 g/dl)Timepoint: 0 to 6 months;Time to achieve target range hemoglobin level of 10–12 g/dLTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactSaajid Hameed
IGIMS, Patna
Outcome results
None listed