End-stage renal disease requiring maintenance hemodialysis
Conditions
Interventions
Intravenous pyridoxal (60 mg thrice weekly after hemodialysis session)
No administration of pyridoxal
Sponsors
PYRAMID Trial Study Group
Department of Geriatric Medicine &
Nephrology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >=20 and <85 years 2) On maintenance hemodialysis over 1 year 3) >20% of transferrin saturation 4) >6 of ERI* *1 defined as the mean weekly ESAs dose per dry weight (kg) during the last 4 weeks divided by hemoglobin level (g/dL) *2 . Ratios of 1:200 and 1:160 will be applied to convert darbepoetin-alfa and epoetin-beta pegol to the epoetin equivalent dose (1 mcg of darbepoetin-alfa = 200 IU of epoetin-alfa or -beta; and 1mcg of epoetin-beta pegol = 160 IU of epoetin-alfa or -beta). 5)Gave written informed consent for participating in the randomized study by the patient himself/herself.
Exclusion criteria
Exclusion criteria: 1) Pyridoxal treatment within 2 months 2) Obvious hemorrhagic disease 3) Hematological disorders other than renal anemia 4) Chronic inflamatory disease (e.g. rheumatoid arthritis, inflamatory bowel diseases) 5) Active malignancy 6) In pregnancy or planning to become pregnant 7) Patients ineligible according to the investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ESA resistance index (ERI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bone turnover markers (BAP and TRAcP-5b) | — |
Countries
Japan
Contacts
Public ContactSatoshi Mikami
Higashi-Kori Hospital Internal Medicine
Outcome results
None listed