Health Condition 1: null- Iron deficient subjects with stage G3-4 chronic kidney disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Iron deficiency defined as TSAT 2. Clinically stable course for last 3 months
Exclusion criteria
Exclusion criteria: 1. Blood haemoglobin 2. Current use or use within last 3 months of oral or intravenous iron preparations 3. Known/ suspected diagnosis of autoimmune disease 4. Past or present diagnosis of malignancy 5. Known diagnosis of chronic liver disease 6. History of any bleeding diathesis 7. History of gastro-intestinal surgery 8. Present or past diagnosis of peptic ulcer disease, gastro-intestinal bleeding or any form of gastro-intestinal disease predisposing to malabsorption 9. Currently taking gastric acid inhibitors (H2 receptor blockers, proton pump inhibitors) 10. History of allergic reactions to any form of oral or intravenous iron preparations 11. History of prior non-compliance with oral iron therapy on account of gastro-intestinal side effects 12. Current use or use within last 6 months of immunosuppressive drug therapy 13. Pregnancy or lactation, in case of females 14. Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in % transferrin saturation with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in serum ferritin at 12 weeks with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. - Change in blood haemoglobin levels at 12 weeks with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. - Change in serum hepcidin levels at 12 weeks with once daily versus twice daily oral iron supplementation in subjects with stage G3-4 CKD and iron deficiency. Timepoint: 12 weeks | — |
Countries
India
Contacts
PGIMER