Chronic Kidney DiseasesINDIGONCT03106298
Iron Deficiency and FGF23 Regulation in CKD and HF
An observational study of Chronic Kidney Diseases and Chronic Heart Failure, run by Northwestern University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Heart Failure, Iron Deficiency Anemia
- What is being tested?
- Iron Sucrose
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2015to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Iron Sucrose
- Keywords
- Iron Deficiency, Fibroblast Growth Factor 23, Phosphate
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SucroseDrug
Also called Venofer
All participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iron Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in c-terminal FGF23 measurements
longitudinal change in plasma c-terminal FGF23 (RU/ml) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Intact FGF23 measurements
longitudinal change in plasma intact FGF23 (pg/ml) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Secondary outcomes (9)
Change in Parathyroid Hormone
longitudinal change in Serum Parathyroid Hormone (pg/ml) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Phosphate (mg/dl)
longitudinal change in Plasma Phosphate (mg/dl) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Serum creatinine
longitudinal change in Serum creatinine (mg/dl) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in 1,25 dihydroxyvitamin D
longitudinal change in 1,25 dihydroxyvitamin D (pg/ml) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in C-reactive protein
longitudinal change in C-reactive protein (mg/L) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Ferritin Measurement
longitudinal change in serum ferritin (ng/ml) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Iron Measurement
longitudinal change in Serum iron (ug/dl) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Transferrin Saturation
longitudinal change in Transferrin Saturation (%) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Hemoglobin Measurement
longitudinal change in Serum hemoglobin (g/dl) over 6 weeks and 3 months
Measured: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start18 Dec 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Responsible party
- Principal investigator, Rupal Mehta, Northwestern University
- Investigators
- Rupal Mehta, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106298
- Sponsor's protocol ID
- STU00201742
- Acronym
- INDIGO
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency and Fibroblast Growth Factor 23 Regulation in Chronic Kidney Disease and Heart Failure
- ClinicalTrials.gov ID
- NCT03106298
- Acronym / sponsor ID
- INDIGO / STU00201742
- Keywords
- Iron Deficiency, Fibroblast Growth Factor 23, Phosphate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Sucrose Treatment | – | Drug: Iron SucroseAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron SucroseAlso: VenoferAll participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes. | Drug | Iron Sucrose Treatment |
Primary outcome
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
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
9 secondary outcomes
Change in Parathyroid Hormone
Time frame: 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
Change in Serum creatinine
Time frame: 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
Change in C-reactive protein
Time frame: 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
Change in Iron Measurement
Time frame: 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
Change in Hemoglobin Measurement
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupal Mehta, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Chronic Heart Failure, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in c-terminal FGF23 measurements (time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.