NCT03633656

Brief Summary

This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

August 14, 2018

Last Update Submit

April 8, 2021

Conditions

Renal Insufficiency, ChronicAnemia, Iron DeficiencyAnemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of tsat values within range

    Tsat is measured as a percent saturation, desired range is 20 to 50%

    Monthly for 6 months

Secondary Outcomes (1)

  • Iron dose over ride by physician

    Monthly for 6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.

Device: Model predictive controlDevice: Model Predictive Control of Iron Dosing

Interventions

Model predictive controlDEVICE

Computer aided dose selection for the treatment of iron deficient anemia.

Treatment
Model Predictive Control of Iron DosingDEVICE

Model Predictive Control of Iron Dosing

Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic kidney disease
  • anemia
  • receiving intravenous iron

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alfred Jacobs, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Professor

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 16, 2018

Study Start

February 1, 2019

Primary Completion

July 31, 2019

Study Completion

August 30, 2019

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)