Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
Study NCT ID:
NCT04231292
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2020-01-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
Sponsor:
Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: