Assessment of the Efficacy and Safety of Desidustat vs Darbepoetin in Anemia due to chronic kidney disease: A Randomized Controlled Trial - NI

Saajid Hameed0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•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.

•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.

发起方

Saajid Hameed