Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD (NCT03903809) | Clinical Trial Compass
UnknownPhase 3
Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD
China175 participantsStarted 2019-06-20
Plain-language summary
The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males or females ≥ 18 years of age.
✓. Females of child-bearing potential who are sexually active had to be willing to practice a highly effective method of birth control for at least 4 weeks prior to randomization, and had to be willing to continue contraception until at least 4 weeks after the last dose of study treatment.
✓. CKD with an estimated glomerular filtration rate \< 60 mL/min/1.73m2 using Collaborative Group on Epidemiology of Chronic Kidney Diseases (CKD-EPI) formula within 4 weeks prior to randomization, and was not expected to begin dialysis for at least 12 weeks.
✓. The patient was not received any erythropoiesis stimulating agents (ESAs) treatment within 12 weeks prior to randomization. And two consecutive hemoglobin values ≥ 6.0 g/dL and \< 10.0 g/dL within 4 weeks prior to randomization.
✓. At least one transferrin saturation (TSAT) ≥ 20% or one serum ferritin (SF) level ≥ 100 ng/ml within 4 weeks prior to randomization. At least one serum folate level and vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to randomization.
✓. Patient was informed of the investigational nature of the study and had given written, informed consent in accordance with institutional, local, and national guidelines.
Exclusion criteria
✕. Females who were pregnant or breast-feeding.
✕. Red blood cell (RBC) or whole blood transfusion within 12 weeks prior to randomization.
✕. Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.
What they're measuring
1
The mean change from the baseline hemoglobin level to the mean level during the evaluation period
✕. Known hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia, hemolytic syndromes, coagulation disorder, etc.) or cause of anemia other than renal disease（e.g. gastrointestinal bleeding or hookworm disease for stool occult blood positive，etc.）.
✕. Known autoimmune diseases（e.g. rheumatoid arthritis, systemic lupus erythematosus, anti-neutrophil cytoplasmic antibody related vasculitis, etc.）.
✕. Obvious infection occurred within 4 weeks prior to randomization，per investigator's clinical judgment.
✕. Chronic, uncontrolled, or symptomatic inflammatory disease，per investigator's clinical judgment.
✕. Uncontrolled or symptomatic secondary hyperparathyroidism，per investigator's clinical judgment.