Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients

Anemia is a common complication of chronic kidney disease with its prevalence increasing with disease progression. The major causes of anemia in patients who have CKD are iron and erythropoietin deficiency. For management of iron deficiency either oral or intravenous iron products are used. Currently Iron Sucrose is being used as drug of choice for intravenous iron replacement for treatment of iron deficiency anemia as standard of care in Pakistan.

Objective of this study is to compare Ferric Carboxymaltose versus Iron Sucrose for treatment of iron deficiency anemia.

This study will be conducted at the department of Nephrology, Sindh Institute of Urology and Transplantation (SIUT), Karachi, Sindh, Pakistan. Data will be collected after taking approval of Institutional review board and Ethical review Committee and informed written consent from the participants.

Participants will be enrolled by principal investigator. All participants will be randomized into two groups by sealed envelopes.

After enrollment, participants will be administered either Ferric Carboxymaltose or Iron Sucrose at daycare clinic of department, Dose will be according to calculated iron deficit though Ganozi formula. Iron deficit(mg) = bodyweight(kg) x (target hemoglobin - actual hemoglobin ) (g/dl) x 2.4 + Iron storage depot(mg).

Medical problems (adverse effects) will be monitored, noted and treated accordingly.

Laboratory parameters such as hemoglobin, serum ferritin and transferrin saturation will be checked at baseline and scheduled visits, which will be compared at the end of study.

After completion of data collection, data analysis will be done using Statistical package for social sciences 26.

• Ferric Carboxymaltose (FCM) (Drug), also known as Ferric Carboxy maltose, Ferinject: This study will dose each patient according to their calculated iron deficit through Ganozi formula Iron deficit(mg) = bodyweight(kg) x (target Hb - actual Hb) (g/dl) x 2.4 + Iron storage depot(mg)
• Iron Sucrose injection (Drug), also known as Venofer: This study will dose each patient according to their calculated iron deficit through Ganozi formula Iron deficit(mg) = bodyweight(kg) x (target Hb - actual Hb) (g/dl) x 2.4 + Iron storage depot(mg)

Primary outcomes

• Change from baseline in hemoglobin concentration [Baseline, Day 28, Day 56]
• Change from baseline in Transferrin Saturation (TSAT) [Baseline, Day 28, Day 56]: Transferrin Saturation (TSAT) will be calculated as: TSAT (%) = 100 x Serum Iron/Total Iron binding capacity (TIBC)
• Change from baseline in serum Ferritin [Baseline, Day 28, Day 56]

Secondary outcomes

• Safety, as measured by number of subjects with at least one adverse event [Baseline, Day 28, Day 56]

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Outpatients
* Between age 18-85 years
* Patients diagnosed with Chronic kidney disease having eGFR of less than 60 ml/kg/1.73m2 (not on maintenance dialysis)

Exclusion Criteria:

* Patients on maintenance dialysis
* Patients with concomitant B12 or folate deficiency
* Patients receiving ESA therapy
* Patients with prior Iron replacement therapy within preceding 2 weeks
* Patients receiving blood transfusions within preceding 3 months
* Pregnant Females
* Patients with Upper GI Bleeding
* Patients with history of hematologic disorders, active malignancy or chronic inflammatory conditions like tuberculosis or ulcerative colitis

• Results publication: 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. PMID 20466657
• Results publication: 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. PMID 23963731

• Kamlesh Kumar, MBBS, (FCPS Resident), Principal investigator, Sindh Institute of Urology and Transplantaion