post renal transplant anemi
Conditions
Interventions
pegmolesatide treatment group:None.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants who meet all of the following criteria are eligible for inclusion: 1. Age: 18-70 years, regardless of sex. 2. Body weight >=45 kg. 3. Experience of allogeneic kidney transplantation for the first time at our hospital. 4. Diagnosis with post renal transplant anemia, defined as Hb =70 g/L after renal transplantation. 5. Transferrin saturation (TSAT) >=20% or serum ferritin >=75 µg/L. 6. Understanding of the study procedures and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: Participants with any of the following conditions are not eligible for inclusion: 1. Known malignancy, autoimmune disease, gastrointestinal bleeding, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulopathy). 2. Recipients of ABO incompatible kidney transplantation. 3. Postoperative delayed graft function (DGF) or unstable graft function (creatinine level fluctuation >25% in the past 3 months). 4. Known allergy to iron agents or polyethylene glycol molecules. 5. Poorly controlled blood pressure, as determined by the investigator as unsuitable for participation in this study. 6. Acute infection phase and/or C reactive protein >=30 mg/L before enrollment. 7. Treatment history of rHuEPO and/or HIF-PHI within the past 4 weeks. 8. Any other factors evaluated by the investigator as unsuitable for participation in this trial, such as inability to be followed up regularly at our hospital.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Hb level at week 12 from baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Hb level at week 12 from baseline.;Mean changes in red blood cell count, hematocrit, and reticulocyte count at each visit from baseline.;Proportion of participants with Hb levels of 10.0-12.0 g/dL and 11.0-13.0 g/dL at each visit.;Mean median time to first Hb level of 11.0-13.0 g/dL during the treatment period.;Hb response rate at each visit.; | — |
Countries
China
Contacts
Public ContactShi Yunying
Department of Nephrology, West China Hospital, Sichuan University
Outcome results
None listed