Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymltose (FCM) | Experimental | Participants will receive intravenous Ferric Carboxymaltose according to their Iron deficit |
|
| Iron Sucrose (IS) | Experimental | Participants will receive intravenous Iron Sucrose according to their Iron deficit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as measured by number of subjects with at least one adverse event | Baseline, Day 28, Day 56 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kamlesh Kumar, MBBS, (FCPS Resident) | Sindh Institute of Urology and Transplantaion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sindh Institute of Urology and Transplantaion | Karachi | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20466657 | Result | 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. | |
| 23963731 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) |
|
|
| 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. |
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided