Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseaseNCT06994065
Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
A study testing Ferric Carboxymaltose (FCM) and Iron Sucrose injection in people with Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
- What is being tested?
- Ferric Carboxymaltose (FCM) and Iron Sucrose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- Ferric Carboxymaltose (FCM), Iron Sucrose injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
Also called 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 injectionDrug
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymltose (FCM) | Experimental | Participants will receive intravenous Ferric Carboxymaltose according to their Iron deficit Receives: Drug: Ferric Carboxymaltose (FCM) |
| Iron Sucrose (IS) | Experimental | Participants will receive intravenous Iron Sucrose according to their Iron deficit Receives: Drug: Iron Sucrose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin concentration
Measured: 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)
Measured: Baseline, Day 28, Day 56
Change from baseline in serum Ferritin
Measured: Baseline, Day 28, Day 56
Secondary outcomes (1)
Safety, as measured by number of subjects with at least one adverse event
Measured: Baseline, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamlesh Kumar, Sindh Institute of Urology and Transplantation
- Investigators
- Kamlesh Kumar, MBBS, (FCPS Resident), Principal investigator, Sindh Institute of Urology and Transplantaion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994065
- Sponsor's protocol ID
- IRONEASE Trial
- Status last verified
- Apr 2025
- First submitted
- 20 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20466657Onken 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.
PubMed 23963731
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06994065
- Acronym / sponsor ID
- IRONEASE Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymltose (FCM) | Experimental | Drug: Ferric Carboxymaltose (FCM)Participants will receive intravenous Ferric Carboxymaltose according to their Iron deficit |
| Iron Sucrose (IS) | Experimental | Drug: Iron Sucrose injectionParticipants will receive intravenous Iron Sucrose according to their Iron deficit |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose (FCM)Also: Ferric Carboxy maltose, FerinjectThis 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) | Drug | Ferric Carboxymltose (FCM) |
| Iron Sucrose injectionAlso: VenoferThis 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) | Drug | Iron Sucrose (IS) |
Primary outcome
Change from baseline in hemoglobin concentration
Time frame: Baseline, Day 28, Day 56
Change from baseline in Transferrin Saturation (TSAT)
Time frame: 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
Time frame: Baseline, Day 28, Day 56
1 secondary outcome
Safety, as measured by number of subjects with at least one adverse event
Time frame: Baseline, Day 28, Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 20466657Szczech 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 publication: PubMed 23963731Onken 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamlesh Kumar, MBBS, (FCPS Resident) principal investigator
Sindh Institute of Urology and Transplantaion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric Carboxymaltose (FCM) and Iron Sucrose injection in people with Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hemoglobin concentration (time frame: Baseline, Day 28, Day 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.