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A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

NCT04231292 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-01-18

No results posted yet for this study

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

Conditions

  • Patient of Anemia in Chronic Renal Failure With Hemodialysis

Interventions

DRUG

RD01

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

DRUG

Recombinant Human Erythropoiesis Injection (CHO cell)

rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin

DRUG

placebo

placebo

Sponsors & Collaborators

  • Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-06-30
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231292 on ClinicalTrials.gov