Erythropoietin versus Desidustat in Anemia due to Chronic Kidney Disease with dialysis Randomized open label active control study - NI

Sri Devaraj Urs Academy of Higher Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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.

•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

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