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| Name | Class |
|---|---|
| National Kidney Foundation, United States | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Sucrose | Drug | All participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in c-terminal FGF23 measurements | 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 | longitudinal change in plasma intact FGF23 (pg/ml) over 6 weeks and 3 months | Weekly x 6 weeks, 1 longitudinal measurement at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parathyroid Hormone | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rupal Mehta, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60607 | United States |
Individual participant data will not be shared with other researchers
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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Serum and plasma samples will be processed and stored in the study freezers with a de-identified study number and collection date.
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | longitudinal change in Serum hemoglobin (g/dl) over 6 weeks and 3 months | Weekly x 6 weeks, 1 longitudinal measurement at 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |