NCT02912494

Brief Summary

The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

September 21, 2016

Last Update Submit

March 29, 2019

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Hemoglobin level

    24 weeks

Study Arms (2)

JR-131

EXPERIMENTAL
Drug: JR-131

Darbepoetin alfa

ACTIVE COMPARATOR
Drug: Darbepoetin alfa

Interventions

JR-131DRUG
JR-131
Darbepoetin alfaDRUG
Darbepoetin alfa

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients being treated with Darbepoetin alfa.

You may not qualify if:

  • Patients having complication or history of a cardiovascular / lung / brain infarction.
  • Patients having a pronounced hemorrhagic lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PMID: 36791280DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations

JP(1)