Efficacy and Safety Study of SAL-0951 in the Treatment of Renal Anemia in Patients Receiving Peritoneal Dialysis

Who may be able to join

• 1.Dry weight 45 to 100 kg; 2.Patients receiving continuous peritoneal dialysis for at least 12 weeks prior to the screening visit and no other blood purification treatment (including hemodialysis) within 12 weeks prior to the screening visit; 3.Patients continuing on peritoneal dialysis during the period between the screening visit and the end of study, without receiving other blood purification treatment (including hemodialysis); 4.Patients with TSAT1 >20% or ferritin1 >50 μg/L at screening visit;
• 1: Invalid test values cannot be used to determine a subject's eligibility. If serum iron values are invalid values, TSAT values shall also be handled as invalid values and re-test will be performed (For patients with ferritin >50 μg/L, there is no need for re-test).
• 5.Patients who have received ESAs within 8 weeks prior to screening visit should meet the following requirements simultaneously ( those with use of darbepoetin alfa (DA) prior to screening should meet all of the following 4 criteria, and those with use of rHuEPO prior to screening should meet both criteria #2 and #4):
• If the treatment drug is DA prior to the screening visit 1, the most recent treatment before the screening visit should be performed 2 weeks (including 2 weeks) prior to the screening visit 1;
• Treatment prescription regimen (including rHuEPO or DA, in which DA needs to be administered on the day of visit 1) consistent with the most recent ESAs prior to screening should be received at the screening visit 1 (same ESAs should be administered at the same dose; if the weekly dose is uneven in the regimen of the most recent ESAs prior to screening, for example, rHuEPO 5000 IU and 3000 IU are injected once every week alternately, proceed the treatment as per original regimen in the screening period; if rHuEPO is originally administered multiple doses weekly and the date of recent dose is less than 3 days from the day of the first dose of study drug, rHuEPO should be discontinued; if rHuEPO is originally administered weekly, the day of rHuEPO administration should be 3 days before the day of the first dose of study drug. Among them, rHuEPO of different brands is regarded as the same kind of ESAs. The acceptable average weekly dose is ≥750 IU and ≤9000 IU in a cycle of treatment based on the last prescription prior to screening, usually 4 weeks.);
• If the treatment drug is DA prior to screening visit 1, the acceptable average weekly dose is 10 µg to 30 µg in a cycle of treatment based on the last prescription of DA prior to screening, usually 4 weeks. It is not expected to receive DA from the day after screening visit 1 until the first dose of study drug according to the original dosing regimen, except in exceptional cases*1;