Iron Deficiency and FGF23 Regulation in CKD and HF

NCT03106298 | Completed FDA Drug

• 1 other identifier: STU00201742
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Kidney Diseases; Chronic Heart Failure; Iron Deficiency Anemia

Keywords

Iron Deficiency; Fibroblast Growth Factor 23; Phosphate

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Change in Parathyroid Hormone

  Weekly x 6 weeks, 1 longitudinal measurement at 3 months

• Change in Phosphate (mg/dl)

  Weekly x 6 weeks, 1 longitudinal measurement at 3 months

• Change in Serum creatinine

  Weekly x 6 weeks, 1 longitudinal measurement at 3 months

• Change in 1,25 dihydroxyvitamin D

  Weekly x 6 weeks, 1 longitudinal measurement at 3 months

• Change in C-reactive protein

  Weekly x 6 weeks, 1 longitudinal measurement at 3 months

Study Arms (1)

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

Interventions

Iron Sucrose DRUG

All participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes.

Also known as: Venofer

Iron Sucrose Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Kidney Foundation, United States: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60607, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples will be processed and stored in the study freezers with a de-identified study number and collection date.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Rupal Mehta, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine/Nephrology

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 10, 2017
• Study Start: December 18, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)