Health Condition 1: N18- Chronic kidney disease (CKD)
Conditions
Interventions
Intervention1: Intravenous iron isomaltoside: Patients in the experimental arm will receive IV Iron isomaltoside 1 gm after test dose over 20 minutes. After administration patient will be monitored fo
Sponsors
Shrinath Mashale
Eligibility
Inclusion criteria
Inclusion criteria: Age more than 18 years left ventricular ejection fraction less than 50% NYHA class 2-4 CKD with estimated glomerular filtration rate less than 60 ml/min/1.73m2 Iron deficiency serum iron less than 800ug/ml and transferrin saturation less than 30% No previous exposure to intravenous iron therapy within last 3 months
Exclusion criteria
Exclusion criteria: Haematological criteria serum ferritin more than 800ug/ml Transferrin saturation more than 30 % CKD patients on maintenance hemodialysis Already received IV iron contraindications to iron therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Exercise capacity measured by the six-minute walk test (6MWT) 2)New York Heart Association (NYHA) functional class 3)eGFR 4)MACETimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| •Hemoglobin concentration in CKD patients with anemia. •Improvement in iron indices (e.g., serum ferritin, transferrin saturation) •Ejection fraction •Cardiac markers(pro BNP ,TropT) Safety Outcomes: •Adverse events related to intravenous iron administration. •Infections or complications associated with CKD management Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactShrinath Mashale
Post graduate institute of medical education and research
Outcome results
None listed