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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The mean change from the baseline hemoglobin level to the mean level during the evaluation period
. 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.
. 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.