Iron Deficiency and FGF23 Regulation in CKD and HF (INDIGO)

March 18, 2019 updated by: Rupal Mehta, Northwestern University

Iron Deficiency and Fibroblast Growth Factor 23 Regulation in Chronic Kidney Disease and Heart Failure

This study investigates the effects of intravenous (IV) iron sucrose therapy on blood levels of Fibroblast Growth Factor 23 (FGF23, a protein that regulates the amount of phosphate in the body) in iron deficiency anemia in healthy participants, participants with Congestive Heart Failure (CHF, where the heart does not pump adequate blood supply to the body), participants with Chronic Kidney Disease (CKD, where the kidney function is reduced), and participants with CKD and CHF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Iron is a key part of our red blood cells which bring oxygen to our body's tissues. Without iron, our blood cannot carry oxygen. The body normally gets iron through diet and it also re-uses iron from old red blood cells. When iron stores are low, patients get iron deficiency anemia. This can happen because patients lose more red blood cells and iron than the body can replace, the body does not do a good job at absorbing iron from the diet, or the body is able to absorb iron but patients are not getting enough iron from their diets. Many patients with chronic diseases such as CKD and CHF also have iron deficiency anemia.

Iron deficiency may also cause a hormone in the body named FGF23 to rise. FGF23 is a hormone that is made in bone and has an important role in the heart and kidney. When the kidneys are not working properly, as in CKD, or when the heart is not pumping correctly, as in CHF, FGF23 levels in the blood go up. Many patients with CKD or CHF also have low levels of iron. In these cases, FGF23 levels may rise even more. Too much FGF23 in the blood may lead to an increased risk of heart problems and accelerate loss of kidney function. The best way to control FGF23 levels in the blood in CKD and CHF is not known.

The investigators are conducting a 6-week iron deficiency anemia study on healthy individuals,individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iron sucrose therapy can safely and successfully lower FGF23 levels. Iron sucrose has been shown to lower FGF23 in animal models. The short term effects of iron sucrose on FGF23 levels in CKD and CHF are not known.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with iron deficiency anemia will be enrolled (those without CKD or HF, those with CKD only, those with HF only, and those with CKD/HF). They will be given iron sucrose as routine care for treatment of their iron deficiency anemia.

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Ability to understand and the willingness to sign a written informed consent.
  • Iron Deficiency Anemia, as defined by
  • Ferritin level < 100 ng/ml or
  • Transferrin saturation <20% with ferritin 100-350 ng/ml and
  • Hemoglobin < 12 g/dl

Exclusion Criteria:

  • Hypersensitivity to any component of iron sucrose
  • Malignancy within 5 years
  • End stage renal disease or kidney transplantation
  • Erythropoiesis stimulating agents
  • Red blood cell transfusions within last 60 days
  • Current radiotherapy or chemotherapy
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 1.5 times normal
  • Hemochromatosis
  • Chronic digestive diseases
  • Pregnancy or nursing
  • Active alcohol or drug abuse
  • Uncontrolled hypertension
  • Active infection
  • Hospitalization in the 4 preceding weeks
  • Concomitant use of antibiotics
  • Concomitant use of immunosuppression
  • Inability to consent.
  • Conditions, in which of the opinion of the investigator, make participation unacceptable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Iron Sucrose Treatment
All patients with iron deficiency anemia (those without CKD or HF, those with CKD only, those with HF only, and those with CKD/HF) will be given 5 weekly doses of 200 mg of intravenous iron sucrose.
Drug: Iron Sucrose
All participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes.
Other Names:
  • Venofer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in c-terminal FGF23 measurements
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in plasma c-terminal FGF23 (RU/ml) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Intact FGF23 measurements
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in plasma intact FGF23 (pg/ml) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Parathyroid Hormone
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in Serum Parathyroid Hormone (pg/ml) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Phosphate (mg/dl)
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in Plasma Phosphate (mg/dl) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Serum creatinine
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in Serum creatinine (mg/dl) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in 1,25 dihydroxyvitamin D
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in 1,25 dihydroxyvitamin D (pg/ml) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in C-reactive protein
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in C-reactive protein (mg/L) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Ferritin Measurement
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in serum ferritin (ng/ml) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Iron Measurement
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in Serum iron (ug/dl) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Transferrin Saturation
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in Transferrin Saturation (%) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Hemoglobin Measurement
Time Frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
longitudinal change in Serum hemoglobin (g/dl) over 6 weeks and 3 months
Weekly x 6 weeks, 1 longitudinal measurement at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Kidney Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rupal Mehta, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00201742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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