Prospective Observational Study of Erythropoietin-Iron In... | NCT01719146

Studies
Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease

NCT01719146

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Oct 27, 2022Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Anemia of End Stage Renal Disease

Interventions

Specimen collection

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

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

ID	Type	Description	Link
R01DK093832	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2022

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

Jan 2013

Primary Completion Date

Jun 5, 2021Actual

Completion Date

Jun 5, 2021Actual

First Submitted Date

Oct 29, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Nov 1, 2012Estimated

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

Oct 25, 2022

Last Update Posted Date

Oct 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adam Edward Gaweda, Associate Professor, University of LouisvillePrincipal Investigator

Lead Sponsor

University of LouisvilleOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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 prospectively collect data on doses of Erythropoietic Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and iron status. These data will be used to derive mathematical models which will subsequently guide dosing of both agents, such that a desired therapeutic outcome is achieved in every patient, while minimizing patient exposure to both agents.

Detailed Description

Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek treatment (Wed/Thu) to measure:

Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor

Weekly ESA and Iron dose delivered will also be recorded.

From these data:

a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
a mathematical model will be established to correlate iron dose with iron markers.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
UofL Subjects	Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY	Other: Specimen collection
Duke Subjects	Subjects undergoing Specimen Collection at Duke University, Durham, NC	Other: Specimen collection
WNERTA Subjects	Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA	Other: Specimen collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Specimen collection	Other	At the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin Concentration (g/dL)	Weekly Hemoglobin Concentration	52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Transferrin Saturation (%)	Weekly Transferrin Saturation	52 weeks
Serum Ferritin (ng/mL)	Weekly Serum Ferritin	52 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

receiving or expected to receive ESA

Exclusion Criteria:

life expectancy less than 12 months
frequent (once or more per month w/in last 6 months) uncontrolled blood loss
frequent (once or more per month w/in last 6 months) hospitalization
frequent (once or more per month w/in last 6 months) access complications

Accepts Healthy Volunteers

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

End Stage Renal Disease Patients undergoing hemodialysis treatments at:

University Kidney Center, Louisville, KY
Duke University, Durham, NC
WNERTA, Springfield, MA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam E Gaweda, Ph.D.	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville, University Kidney Center		Louisville	Kentucky	40202	United States
Western New England Renal and Transplant Associates

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D051436	Renal Insufficiency, Chronic
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013048	Specimen Handling

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided