An approach to intravenous Iron therapy in patients receiving dialysis regularly

A COMPARATIVE STUDY OF PROACTIVE VERSUS REACTIVE APPROACH TO IV IRON THERAPY IN PATIENTS ON MAINTENANCE DIALYSIS - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058062

Enrollment

Registered

2023-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: nil: nil Control Intervention1: Intravenous Iron isomaltoside: Subjects to receive Intravenous iron supplementation with iron isomaltoside (500 mg) once monthly in Proactive Group or

Eligibility

Inclusion criteria

Inclusion criteria: CKD patients on Maintenance dialysis (hemodialysis or peritoneal dialysis) Age more than 18 years, Duration of Maintenance Dialysis more than 60 days, Hemoglobin less than 11g/dl, Ferritin Follow up in Command Hospital, Eastern Command, Kolkata during study period

Exclusion criteria

Exclusion criteria: Current use of IV Iron therapy or Use of IV or Oral Iron Therapy within last 15days Blood Transfusion in last one month Active infection (bacterial, fungal) Known HIV or Hepatitis B or C Known / suspected diagnosis of autoimmune disease Past or present diagnosis of malignancy Known diagnosis of chronic liver disease History of any bleeding diathesis History of gastro-intestinal surgery in past 3 months Present or past diagnosis of peptic ulcer disease or gastro-intestinal bleeding History of severe allergic reactions to any form of intravenous iron preparations Pregnancy or lactation, in case of females Life expectancy History of acquired iron overload Presence of Macrocytic anemia or Low Vitamin B12 level Patient not giving consent

Design outcomes

Primary

Measure	Time frame
To compare the incidence of fatigue & Quality of life index at the end of 6 months between the two groupsTimepoint: At the end of 6 months	—

Secondary

Measure	Time frame
To compare the incidence of Major Cardiovascular Adverse Events (Non fatal stroke, Non Fatal Myocardial infarction & cardiovascular death)Timepoint: After 6 months;To compare the dose of Erythropoietin Stimulating agents & incidence of serious infections between the two groupsTimepoint: After 6 months	—

Countries

India

Contacts

Public ContactKrishnendu Das

Command Hospital(Eastern Command)

warriorjai11@gmail.com7838843391

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026