Health Condition 1: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: Tablet Desidustat: Patients who have not received erythropoietin, their initial dose of desidustat will be 100 mg oral thrice a week and for those on erythropoietin 50-75 IU/kg once a w
Sponsors
Sri Devaraj Urs Academy of Higher Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender aged more than 18 years clinical diagnosis of anemia due to CKD stage 5 2.Patients on dialysis more than 2 times in a week for at least 4-6 weeks prior to screening 3.Baseline hemoglobin level of 8.0–11.0 g/dL 4.Serum ferritin more than 100ng/mL and not more than 500ng/ml and/or transferrin saturation TSAT more than 20% 5.Patients who do not have deficiency of folate or vitamin B12 after the determination of serum levels 6.Patients who had not received Erythrocyte Stimulating Agents ESA EPO analog EPO naïve for at least 4 weeks prior to screening visit and prior ESA users patients on a stable dose of ESA at least 4 weeks prior to screening 7.Patients who will be on stable dose of ESA for atleast 4 weeks prior to screening more than 30percent of dose change.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension SBP more than 200 mmHg or DBP more than 110 mmHg at screening visit before dialysis 2.Previous history of kidney transplant 3.Patients who have received blood transfusion within 8 weeks prior to screening 4.Patients with hepatitis B or C infection as per serology or Human immunodeficiency virus HIV infection. 5.Previous history of or currently diagnosed to have malignancy 6.Patient receiving high dose of erythropoietin at screening visit. Erythropoietin of =450 IU/kg/week intravenous or more than 300 IU/kg/week subcutaneous 7.Patients who have undergone major surgery in the past 3 months 8.Malabsorption syndrome, resection of the small bowel or inflammatory bowel disease 9.History of bleeding disorders 10.Stroke or intracranial hemorrhage prior to enrollment 11.Had history of allergy to Desidustat or Erythropoietin 12.Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the change in the hemoglobin level between desidustat and erythropoietin in patients with chronic kidney disease (CKD) undergoing dialysis 2.To assess the adverse effects using WHO causality assessment scale Timepoint: Baseline and week 4 8 12 16 20 24 Week 4 12 24 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of patients with hemoglobin responseTimepoint: 16 and 24 weeks | — |
Countries
India
Contacts
Public ContactShobhana Nayak Rao
Sri Devaraj Urs Medical College
Outcome results
None listed