Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
Conditions
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.
Interventions
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)
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)
Sponsors
Sindh Institute of Urology and Transplantation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety, as measured by number of subjects with at least one adverse event | Baseline, Day 28, Day 56 |
Countries
Pakistan
Contacts
Primary ContactKamlesh Kumar, MBBS, (FCPS Resident)
Backup ContactSyed Sarfraz Sarwar, MBBS, FCPS
Outcome results
None listed