Randomized controlled trial to compare the safety and efficacy of desidustat with erythropoietin in adult patient suffering from anemia in chronic kidney disease. - nil

Dr Sachin Sharma0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1. Patient willing to give written informed consent. 2.Age more than 18 years. 3.Male or female patient with current clinical diagnosis of anemia due to CKD having baseline hemoglobin concentrations =10.0 g/dl before the enrolment. 4)If patients are on dialysis they should be on adequate dialysis (as prescribed) on either 2 or 3 times per week hemodialysis for at least 12 weeks prior to screening. 5)Patients with no planned renal transplant during study period. 6)Adequate serum ferritin and/or TSAT as per KDIGO guidelines. 7)No iron, folate or vitamin B12 deficiency.

•1.Age less than 18 years.
•2.Patients who received red blood cell transfusion within 8 weeks prior to enrollment.
•3.Hematological malignancy or primary hematological disease.
•4.Malignancy of any organ.
•5.Presence or a history of bleeding disorder.
•6.Serological status reflecting active hepatitis B or C or Human immunodeficiency virus (HIV) infection.
•7.History of renal transplant.
•8.Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestinal absorption such as mal absorption syndrome, resection of small bowel or poorly controlled inflammatory bowel disease affecting small intestine.
•9.History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
•10.Known hypersensitivity to investigational products or with known contraindications to any of the study drug.
•11.Women who are trying to conceive, pregnant and breast-feeding women.

发起方

Dr Sachin Sharma