None listed
Conditions
Interventions
Drug : Eligible patients will be randomized (1:1) following the screening period.
1) subjects who received subcutaneous methoxy polyethylene glycol-epoetin beta
->
starting dose of 1.2 µg/kg/month over a 12-week correction period, followed by a 24-week evaluation period
2) subjects who received subcutaneous darbepoetin alfa
->
starting dose will be determined after 2 weeks of administration of 0.45 µg/kg
when Hb (hemoglobin) rises after two weeks: administer twice the starting dose (0.9 µg/kg/month)
when Hb dose not rises a
(1.125 µg/kg/month)
->
8-week correction period, followed by a 24-week evaluation period
Both drug dose will be adjusted by ~25%
during the correction phase until the response level (Hb increase of =1 g/dL above the baseline and at a value =10 g/dL) will be reached. If Hb levels exceeded 11 g/dL, treatment was temporarily inter
11 g/dL, treatment with both drug will be restarted at a dose ~25%
below that previously administered. Dosing intervals will be remained unchanged throughout the study, and dose adjustments will be made during scheduled visits, no more frequently than monthly. In ca
100 lg/L, TSAT <
20%
), the protocol specified that iron supplementation will be administered orally or intravenously during the screening and treatment periods.
Sponsors
Soon Chun Hyang University Hospital Bucheon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age (confirm at screening only): 18-99 years of age; (2) KDOQI CKD stages 4 or 5 using CKD Epidemiology collaboration (CKD-EPI) formula and were not on dialysis; (3) who had Hb 8 to 10 g/dL at baseline; adequate iron status (serum ferritin and transferrin saturation =100 ng/mL and =20%, respectively)
Exclusion criteria
Exclusion criteria: (1) Active cancer patients; (2) who was diagnosed decompensated liver cirrhosis and heart failure; (3) who had Arrhythmia, Asthma, COPD; adequate iron status (serum ferritin and transferrin saturation =100 ng/mL and =20%, respectively); (4) who have been treated erythropoietin stimulating agents (ESAs) previously; (5) who had history of GI bleeding, hemorrhage by trauma and menorrhagia; (6) pregnent woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean change in Hb between baseline and efficaty evaluation period (EEP) | — |
Secondary
| Measure | Time frame |
|---|---|
| N (%) responders, defined as mean Hb within the Hb analysis range 10-11 g/dL during EEP;% time Hb in analysis range (10-11 g/dL) during the EEP | — |
Countries
Korea, Republic of
Contacts
Public ContactByung Chul Yu
Soon Chun Hyang University Hospital Bucheon
Outcome results
None listed