end stage kidney disease end stage kidney disease, hemodialysis, renal anemia, carnitine deficiency
Conditions
Interventions
Patients on continuous hemodialysis with carnitine deficiency and anemia are divided into two groups: enalodustat tablets or darbepoetin alfa tablets.
Sponsors
Hayashi Terumasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients on maintenance hemodialysis three times a week for at least 3 months who meet all of the following criteria will be included in this study. 1) Patients of18 years or more and less than 85 years at the time of consent 2) Patients receiving ESA for 3 months or more at the time of consent 3) Patients with suspected carnitine deficiency (Dialysis-related carnitine disorder, DCD) 4) Patients with Hb level < 11g/dL measured 2 time points at least ore week apart within 4 weeks prior to the enrollment 5) Patients with a ferritin level of 100 ng/ml or more orTSAT level of 20% or more within 4 weeks prior to enrollment 6) Patients receiving appropriate dialysis therapy for end-stage kidney disease 7) Patients whose written consent has been obtained by the patient
Exclusion criteria
Exclusion criteria: 1) Patients with coronary artery disease 2) Patients with heart failure of NYHA class III or higher 3) Patients diagnosed with dilated or hypertrophic cardiomyopathy 4) Patients who had a stroke within 24 weeks prior to the date of consent 5) Patients with a history of thromboembolic events other than cerebro- or cardio-vascular lesion 6) Patients with poorly controlled diabetic retinopathy or age-related macular degeneration 7) Patients with recurrent muscle spasms requiring treatment during dialysis 8) Patients with treatment-resistant hypotension during dialysis 9) Patients with uncontrolled hypertension (> 180/110 mmHg) 10) Patients with vitamin B12 deficiency or folate deficiency (below the facility's lower reference limit) within 4 weeks prior to the enrollment 11) Patients with gastrointestinal bleeding 12) Patients with malignant tumor or hematopoietic disease *except for malignant tumors that are considered curable 13) Patients with liver cirrhosis 14) Patients with inflammatory diseases such as vasculitis and autoimmune disease 15) Pregnant or lactating patients or those who plan to become pregnant or wish to become pregnant during the study period 16) Patients who have used HIF-PH inhibitors within 6 months prior to consent 17) Patients who have experienced adverse reactions to HIF-PH inhibitors in the past 18) Patients whose physician has determined that they are inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb level at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage of patients in each group achieving one of the following: If baseline Hb level less than 9.5 g/dL, increase in Hb level of 1 g/dL or more at 24 weeks If baseline Hb level of 9.5 g/dL or more and less than 10 g/dL, increase in Hb level of 0.5 g/dL or more at 24 weeks If baseline Hb level of 10g/dL or more and less than 11 g/dL, Hb maintained at 10 g/dL or more and less than11 g/dL with no decrease of 0.5 g/dL or more at 24 weeks 2) Change from baseline in total carnitine, free carnitine and acylcarnitine levels at 24 weeks post-allocation 3) Change from baseline in BMIPP SS at 48 weeks post-allocation 4) Hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death including sudden death during the follow-up period 5) All-cause mortality during the follow-up period | — |
Contacts
Public ContactTerumasa Hayashi
Osaka General Medical Center
Outcome results
None listed