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

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ClinicalTrials.gov Identifier: NCT03106298
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by (Responsible Party):
Rupal Mehta, Northwestern University

March 22, 2017
April 10, 2017
April 10, 2017
December 18, 2015
January 1, 2020   (Final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Iron Deficiency and FGF23 Regulation in CKD and HF
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.

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.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum and plasma samples will be processed and stored in the study freezers with a de-identified study number and collection date.
Non-Probability Sample
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.
  • Chronic Kidney Diseases
  • Chronic Heart Failure
  • Iron Deficiency Anemia
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 Name: Venofer
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.
Intervention: Drug: Iron Sucrose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
January 1, 2020
January 1, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Rupal Mehta, MD 312-503-1536 rupal.mehta@northwestern.edu
United States
 
 
NCT03106298
STU00201742
No
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
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers
Rupal Mehta, Northwestern University
Northwestern University
National Kidney Foundation
Principal Investigator: Rupal Mehta, MD Northwestern University
Northwestern University
April 2017