A Long-term Study of JR-131 in Renal Anemia Patients With... | NCT02912533

Studies
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

NCT02912533

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Apr 2, 2019Actual

Enrollment

Not provided

Phase

Phase 3

Conditions

Anemia

Interventions

JR-131

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Sep 21, 2016

First Submission Date that Met QC Criteria

Sep 21, 2016

First Posted Date

Sep 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2019

Last Update Posted Date

Apr 2, 2019Actual

Name	Class
JCR Pharmaceuticals Co., Ltd.	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
JR-131	Experimental		Drug: JR-131

Name	Type	Description	Arm Group Labels	Other Names
JR-131	Drug		JR-131

Measure	Description	Time Frame
Measure adverse events		52 weeks

Measure	Description	Time Frame
Hemoglobin level		52 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients being treated with erythropoiesis stimulating agent.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided