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Study of rESP Injection for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

NCT03950687 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-03-09

No results posted yet for this study

Summary

A phase 2, randomized, open label, active comparator parallel controlled study to explore the dosage regiment of rESP, and evaluate its efficacy, safety and pharmacokinetic characteristics in the treatment of anemia in chronic renal failure patients with hemodialysis

Conditions

  • Chronic Renal Failure With Hemodialysis

Interventions

DRUG

Recombinant Human Erythropoiesis Injection (CHO cell)

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

DRUG

Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)

rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

Sponsors & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2020-06-30
Completion
2020-12-30

Countries

  • China

Study Locations

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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 NCT03950687 on ClinicalTrials.gov