Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

NCT04464850 | Unknown Phase 3

• 1 other identifier: MED-2563-07092
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aim to compare the efficacy of intravenous versus oral iron therapy regarding the hemoglobin levels, iron status and erythropoietin dosage in maintenance hemodialysis patients

Conditions

Hemodialysis Complication; Anemia; Iron Deficiency Anemia

Keywords

Iron therapy; Hemodialysis; Iron status; Epoetin dose; Intravenous iron; Oral iron

Outcome Measures

Primary Outcomes (1)

• Changes of epoetin dose

  Hemoglobin levels will be monitored and epoetin dose will be adjusted according to hemoglobin levels at 4, 12, 24 weeks after randomization. Protocols for epoetin dose adjustments are shown as follow. Hemoglobin levels (g/dl) Epoetin dose adjustment \<9.0 Increased by 50% 9.0 to \<10.0 Increased by 25% 10.0 to \<11.5 No change 11.5 to \<12.5 Decreased by 25% * 12.5 Decreased by 50%

  24 weeks after randomization

Secondary Outcomes (9)

• Hemoglobin levels

  4, 12, 24 weeks after randomization

• Erythropoietin resistance index

  4, 12, 24 weeks after randomization

• Major cardiovascular events (MACE)

  24-week period after randomization

• Unscheduled hospitalization

  24-week period after randomization

• Hospitalization due to infections

  24-week period after randomization

Study Arms (2)

Intravenous iron

EXPERIMENTAL

Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day

Drug: Intravenous iron

Oral iron

ACTIVE COMPARATOR

Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day

Drug: Oral iron

Interventions

Intravenous iron DRUG

Iron sucrose will be given by continuous infusion for 1 hour during the last 1 hour of dialysis session. Iron sucrose will be given for 24 weeks during study period. Serum ferritin will be monitored at 4, 12, and 24 weeks after randomization. The dosage of intravenous iron will be adjusted according to serum ferritin levels as follows. Serum ferritin \<500 mg/dl: iron sucrose 100 mg every 2 weeks Serum ferritin 500-800 mg/dl: iron sucrose 100 mg every 4 weeks Serum ferritin \>800 mg/dl: discontinue iron sucrose

Also known as: Venofer, Encifer

Intravenous iron

Oral iron DRUG

1 tablet, three times a day, of iron fumarate will be prescribed for 24 weeks of study period. The dosage of iron fumarate will be adjusted according to serum ferritin levels as follows. Serum ferritin will be monitored at 4, 12, and 24 weeks after randomization. Serum ferritin \<500 mg/dl: iron fumarate 200 mg three times daily Serum ferritin 500-800 mg/dl: iron fumarate 200 mg once daily Serum ferritin \>800 mg/dl: discontinue iron fumarate

Also known as: Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)

Oral iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Hemodialysis for at least 3 months
• Hemoglobin levels between 8 and 11.5 g/dl inclusive
• Transferrin saturation (TSAT) \<50% and ferritin \<800 mg/dl
• Stable dose of epoetin of any types and iron therapy for at least 1 month

You may not qualify if:

• History of iron allergy
• Pregnant or lactating women
• Patients with known hematologic disorders other than anemia of renal disease and iron deficiency anemia
• Patients with hemoglobinopathy e.g., thalassemia
• Patients with iron overload or hemochromatosis
• Patients with gastrointestinal hemorrhage during 6 months before enrolment in to the study
• Patients with current severe infection
• Patients with any malignancies
• Patients with severe psychiatric illness
• Patients with any other medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
• Patients who currently receive medications that can altered gastrointestinal absorption of oral iron e.g., aluminum carbonate, aluminum hydroxide, chloramphenicol, dimercaprol

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

Ferric Oxide, Saccharated; Iron; ferrous fumarate; Folic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; 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; Metals, Heavy; Elements; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kajohnsak Noppakun, MD

  Instructor, Division of Nephrology, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kajohnsak Noppakun, MD

CONTACT

+66815953465; kajohnsak.noppakun@cmu.ac.th

Tiranun Suriya, RN

CONTACT

+66818812106; tingsuri@hotmail.co.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Maintenance hemodialysis patients who are eligible to enrol into the study according to inclusion and exclusion criteria will be start with 2-week run-in period before randomization. During this run-in period, all iron supplements that patients receive including oral and intravenous iron will be discontinued.

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: July 29, 2020
• Primary Completion: January 31, 2021
• Study Completion: July 31, 2022
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)