A Randomized Study of the Safety and Efficacy of FG-2216... | NCT00456053 | Trialant

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A Randomized Study of the Safety and Efficacy of FG-2216... | NCT00456053 | Trialant

Studies
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

NCT00456053

Sponsor

Kyntra Bio

Status

Completed

Last Update Posted

Nov 6, 2007Estimated

Enrollment

145Actual

Phase

Phase 2

Conditions

Renal Anemia

Interventions

FG2216

Countries

United States

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

NCT00456053

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

FGCL-SM2216-019

Secondary IDs

Not provided

Brief Title

A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

Official Title

A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

Acronym

Not provided

Organization

Kyntra BioINDUSTRY

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Apr 2, 2007

First Submission Date that Met QC Criteria

Apr 2, 2007

First Posted Date

Apr 4, 2007Estimated

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

Nov 2, 2007

Last Update Posted Date

Nov 6, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Kyntra BioINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.

Detailed Description

Not provided

Conditions Module

Conditions

Renal Anemia

Keywords

Renal Anemia
Renal Failure
Kidney Disease
Human EPO

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FG2216	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin (Hb) response

Secondary Outcomes

Measure	Description	Time Frame
Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage 3 or 4 chronic kidney disease
appropriate hemoglobin levels

Exclusion Criteria:

Neovascular age related macular degeneration requiring treatment
Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
Any history of malignancy
Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
Renal Transplant

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona		United States
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Randomized

Intervention Model

Factorial Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Single

Masking Description

Not provided

Who Masked

Not provided

Little Rock

Arkansas

United States

3 Research Sites

Los Angeles

California

United States

Research Site

Oakland

California

United States

Research Site

San Diego

California

United States

Research Site

Santa Clara

California

United States

Research Site

Lauderdale Lakes

Florida

United States

Research Site

Miami

Florida

United States

Research Site

Pembroke Pines

Florida

United States

Research Site

Atlanta

Georgia

United States

Research Site

South Holland

Illinois

United States

Research Site

Shreveport

Louisiana

United States

Research Site

Springfield

Massachusetts

United States

Research Site

Kalamazoo

Michigan

United States

Research Site

Pontiac

Michigan

United States

Research Site

Flushing

New York

United States

Research Site

Cincinnati

Ohio

United States

Research Site

Columbus

Ohio

United States

Research Site

Portland

Oregon

United States

Research Site

Allentown

Pennsylvania

United States

Research Site

Hershey

Pennsylvania

United States

Research Site

Pittsburgh

Pennsylvania

United States

Research Site

Orangeburg

South Carolina

United States

Research Site

Houston

Texas

United States

Research Site

San Antonio

Texas

United States

Research Site

Chesapeake

Virginia

United States

Research Site

Fairfax

Virginia

United States

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided