Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney D… (NCT03902691) | Clinical Trial Compass
CompletedPhase 3
Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis
China372 participantsStarted 2019-05-15
Plain-language summary
The purpose of this study is to evaluate the effecacy and safety of dialysis centers switching its dialysis patients from using recombinant human erythropoietin injection (CHO Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males or females ≥18 and ≤70 years of age, weight ≥ 45 kilograms (kg).
✓. 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.
✓. Participants with chronic renal failure on dialysis（hemodialysis/ peritoneal dialysis） for ≥ 3 months prior to randomization，and that the frequency of dialysis was stable and no change in dialysis pattern was observed during the trial.
✓. On ESAs treatment for ≥8 weeks prior to screening stage with stable doses and the average doses ≤ 10000 IU/week. And two consecutive hemoglobin values ≥10.0 g/dL and ≤12.0 g/dL within 4 weeks prior to randomization.
✓. At least one transferrin saturation (TSAT) ≥ 20% and 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.