CKD Dialysis Anemia
Conditions
Interventions
Combination therapy (rHuEPO HIF-PHI) switching to pemosertib treatment group:NA
rHuEPO switched to the pemosanitide treatment group:NA
HIF-PHI switched to the pemafibrate treatment group:NA
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Diagnosed with stage 5 CKD, having received at least 6 months of hemodialysis (possibly combined with hemodiafiltration at a stable frequency) or peritoneal dialysis treatment prior to enrollment, with stable dialysis frequency and no planned changes to the dialysis method during the trial; 3. Most recent dialysis adequacy assessment before enrollment meets standards (hemodialysis spKt/V >= 1.2, peritoneal dialysis Kt/V >= 1.7); 4. The participant has been on regular follow-up at this center for more than 6 months prior to screening, and the center's electronic medical record database contains more than 3 Hb test results, with at least 3 weeks between tests; 5. Before enrollment, the participant has been receiving rHuEPO and/or HIF-PHI treatment continuously for at least 12 weeks without changing the medication regimen; 6. The participant understands the study procedures and voluntarily signs an informed consent form approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant or breastfeeding; 2. Known to have systemic blood disorders or hemolytic anemia, myelofibrosis, myelodysplastic syndromes, or anemia caused by bleeding lesions; 3. Have received red blood cell transfusion within 12 weeks prior to enrollment; 4. Planning to undergo kidney transplantation during the study period or already a kidney donor; 5. History of neurological/psychiatric disorders, including psychosis or dementia, or other reasons that severely affect compliance; 6. Known or suspected allergy to any component of the study drug; 7. Currently participating in other clinical studies; 8. Subjects whom the investigator deems have other reasons making them unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall Hb compliance rate of the population at each visit point; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average Hb values at each follow-up point in the two studies;The proportion of subjects achieving Hb targets (Hb target range: 110g/L<= Hb <=130g/L) at each follow-up point in the two studies; | — |
Countries
China
Contacts
Public ContactChen Lei
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed