Clinical trial NCT06994065: Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
Official title: Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
Lead sponsor: Sindh Institute of Urology and Transplantation
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in hemoglobin concentration
timeFrame: Baseline, Day 28, Day 56
measure: Change from baseline in Transferrin Saturation (TSAT)
timeFrame: Baseline, Day 28, Day 56
measure: Change from baseline in serum Ferritin
timeFrame: Baseline, Day 28, Day 56
Secondary outcomes:
measure: Safety, as measured by number of subjects with at least one adverse event
timeFrame: Baseline, Day 28, Day 56
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Urology and Transplantaion
state: Sindh
Study officials:
affiliation: Sindh Institute of Urology and Transplantaion
name: Kamlesh Kumar, MBBS, (FCPS Resident)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.