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

NCT06994065 | Completed

• 1 other identifier: IRONEASE Trial
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

• Change from baseline in hemoglobin concentration

  Baseline, Day 28, Day 56

• Change from baseline in Transferrin Saturation (TSAT)

  Transferrin Saturation (TSAT) will be calculated as: TSAT (%) = 100 x Serum Iron/Total Iron binding capacity (TIBC)

  Baseline, Day 28, Day 56

• Change from baseline in serum Ferritin

  Baseline, Day 28, Day 56

Secondary Outcomes (1)

• Safety, as measured by number of subjects with at least one adverse event

  Baseline, Day 28, Day 56

Study Arms (2)

Ferric Carboxymltose (FCM)

EXPERIMENTAL

Participants will receive intravenous Ferric Carboxymaltose according to their Iron deficit

Drug: Ferric Carboxymaltose (FCM)

Iron Sucrose (IS)

EXPERIMENTAL

Participants will receive intravenous Iron Sucrose according to their Iron deficit

Drug: Iron Sucrose injection

Interventions

Ferric Carboxymaltose (FCM) DRUG

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)

Also known as: Ferric Carboxy maltose, Ferinject

Ferric Carboxymltose (FCM)

Iron Sucrose injection DRUG

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)

Also known as: Venofer

Iron Sucrose (IS)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantaion

Karachi, Sindh, Pakistan

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

ferric carboxymaltose; Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Kamlesh Kumar, MBBS, (FCPS Resident)

  Sindh Institute of Urology and Transplantaion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Nephrology Resident

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)