FindTrial
Sign In

Randomized controlled trial to compare oral iron to parenteral iron therapy for correction of iron deficiency in chronic kidney disease.

A randomised controlled trial to compare oral iron supplementation in once daily versus alternate day dosage to single dose parenteral iron therapy for correction of iron deficiency in subjects with stage G3-4 chronic kidney disease. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024881
Enrollment
90
Registered
2020-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D508- Other iron deficiency anemias

Interventions

Intervention1: Parenteral iron supplementation with single dose of inj Ferric carboxy maltose for correction of iron deficiency in subjects with CKD stage G3-4.: Single dose of IV inj Ferric carboxy m

Sponsors

Dr Manu Dogra
Lead Sponsor

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 hemoglobin 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 due to 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

MeasureTime frame
Change in blood haemoglobin levels at 24 weeks with alternate day versus once daily oral iron supplementation versus single dose parenteral iron therapy in subjects with stage G3-4 CKD and iron deficiency.Timepoint: 12 weeks and 24 weeks—

Secondary

MeasureTime frame
i. Change in serum ferritin, % transferrin saturation, blood hepcidin, IL-6, TNF-α levels at 24 weeks with once daily versus alternate day oral iron supplementation versus parenteral iron therapy for correction of iron deficiency in subjects with stage G3-4 CKD. 2. Monitoring drug compliance (verbally as well as by pill count) in either arms of oral iron supplementation. 3. Monitor adverse events in the three arms. Timepoint: 24 weeks—

Countries

India

Contacts

Public ContactDr Vivek Sood

Army Hospital (Research and Referral)

viverit@gmail.com8974321019

Outcome results

None listed

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