Patient of Anemia in Chronic Renal Failure With Hemodialysis Clinical Trial
Official title:
A Multicenter, Randomized, Single-blind, Active Comparator Controlled Phase 2 Clinical Study on the Effectiveness, Safety and Pharmacokinetics of Pegerythropoietin Injection (RD01) in Different Medication Schemes for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
This trial is a multicenter randomized, single blind, active comparator controlled phase 2
study. The study is divided into two stages. The first stage lasts for 18 weeks, and is
divided into fixed dose period (day 1~ 6th week ) and dose adjustment period (7th ~ 18th
week). The second stage lasts for 28 weeks, and is also divided into dose adjustment period
(19th ~ 38th week) and evaluation period (39th ~ 46th week).
Patients are randomly assigned to seven study groups in the first stage. Of all these seven
groups, six groups are: Group A (0.8μg/kg RD01, once every two weeks, subcutaneous injection,
for 18 weeks)、Group B (1.2μg/kg RD01, once every two weeks, subcutaneous injection, for 18
weeks)、Group C (1.6μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、
Group D (0.8ug/kg RD01, once every two weeks, intravenous injection, for 18 weeks)、Group E (
150 IU/kg rHuEPO, once a week, subcutaneous injection, for 18 weeks )、Group F (8μl /kg
placebo, once every two weeks, for 6 weeks; then 150 IU/kg rHuEPO, once a week, subcutaneous
injection, 7th ~ 18th week ).
At the beginning of the second stage, some patients in these six goups need to be be
randomized again. Of which patients in Group A、B、C are randomly assigned to Group a ( RD01,
once every two weeks, subcutaneous injection, 19th ~ 46th week )、Group b (RD01, once every
four weeks, subcutaneous injection, 19th ~ 46th week)、Group c (RD01, once every six weeks,
subcutaneous injection, 19th ~ 46th week); Patients in Group D enter directly to Group d
(RD01, once every four weeks, intravenous injection, 19th ~ 46th week); Patients in Group E
and F are randomly assigned to Group e (rHuEPO once a week, intravenous injection, 19th ~
46th week ) and Group f (rHuEPO once a week, subcutaneous injection, 19th ~ 46th week). The
starting dose of the second stage for individual patient in all groups refers to the weekly
dose at the end of the first stage .
During the whole study period, all patients in six groups are not allowed to adjust dosage in
the first 6 weeks, while in the remaining trial period dosage adjustment was allowed once
every two weeks if necessary.
There is a special Group G (1.6μg/kg RD01, once every four weeks, subcutaneous injection, Day
1 ~ 28th week), all patients are allowed to adjust dosage during the whole 28 weeks.
This phase 2 study is to evaluate the effectiveness, safety and the PK/PD characteristics of
different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance
therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
;