drugset / Trial / NCT06994065
Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if Ferric Carboxymaltose is a safe efficacious alternative to Iron Sucrose for treatment of Iron deficiency anemia in non-dialysis dependent chronic kidney disease patients. The main questions it aims to answer are: * Does Ferric Carboxymaltose causes similar or higher rise in hemoglobin concentration and serum Ferritin and transferrin saturation * What medical problems will participants have when receiving Ferric Carboxymaltose Participants will: * Be administered either Ferric Carboxymaltose or Iron Sucrose * Visit the clinic at day 28 and 56 for checkup and tests * Be monitored for any medical problem during and after infusion
Timeline
- Start
- 2025-04-01
- Primary completion
- 2025-09-30
- Completion
- 2025-11-30
Publications
- Results Szczech LA, Bregman DB, Harrington RA, Morris D, Butcher A, Koch TA, Goodnough LT, Wolf M, Onken JE. Randomized evaluation of efficacy and safety of ferric carboxymaltose in patients with iron deficiency anaemia and impaired renal function (REPAIR-IDA): rationale and study design. Nephrol Dial Transplant. 2010 Jul;25(7):2368-75. doi: 10.1093/ndt/gfq218. Epub 2010 Apr 21.
- Results Onken JE, Bregman DB, Harrington RA, Morris D, Buerkert J, Hamerski D, Iftikhar H, Mangoo-Karim R, Martin ER, Martinez CO, Newman GE, Qunibi WY, Ross DL, Singh B, Smith MT, Butcher A, Koch TA, Goodnough LT. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2014 Apr;29(4):833-42. doi: 10.1093/ndt/gft251. Epub 2013 Aug 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | — | Intravenous |
| Subject | Iron sucrose | Unknown | — | Intravenous |