Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

NCT ID: NCT04464850

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2022-07-31

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

Detailed Description

Run-in phase: All eligible patients will enter run-in phase for 2 weeks. In this phase, all oral therapy that patients received before enrolment into the study will be discontinued.

Masking: Opened label

Allocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron

Safety criteria: Study participants who meet the following criteria will be discontinued from the study. All patients data will be analyzed according to intention-to-treat principles.

• Hemoglobin levels < 6.0 g/dl
• Packed red cells transfusion is required
• Serum ferritin >1,000 md/dl

Conditions

Hemodialysis Complication; Anemia; Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intravenous iron

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

Group Type: EXPERIMENTAL

Intravenous iron

Intervention Type: 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

Oral iron

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

Group Type: ACTIVE_COMPARATOR

Oral iron

Intervention Type: 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

Interventions

Intravenous iron

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

Intervention Type: DRUG

Oral iron

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

Intervention Type: DRUG

Other Intervention Names

Venofer, Encifer; Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Kajohnsak Noppakun

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kajohnsak Noppakun, MD

Role: PRINCIPAL_INVESTIGATOR

Instructor, Division of Nephrology, Department of Internal Medicine

Locations

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

Chiang Mai, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Kajohnsak Noppakun, MD

Role: CONTACT

kajohnsak.noppakun@cmu.ac.th

+66815953465

Tiranun Suriya, RN

Role: CONTACT

tingsuri@hotmail.co.th

+66818812106

Facility Contacts

Kajohnsak Noppakun, MD

Role: primary

kajohnsak.noppakun@cmu.ac.th

+66815953465

Tiranun Suriya, RN

Role: backup

tingsuri@hotmail.co.th

+66818812106

Other Identifiers

MED-2563-07092

Identifier Type: -

Identifier Source: org_study_id