Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Ferric Citrate: Ferric citrate in the treatment of hyperphosphatemia in patients with Chronic Kidney Disease stage 3 to 5D
Control Intervention1: Sevelamer: Comparison of Ferric citrate
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years with eGFR 2. Patients who are not taking phosphate binders with serum phosphate level > 6mg/dl and 3. Patients who had discontinued phosphate binders for > 2weeks with serum phosphate level > 6mg/dl and < 10mg/dl
Exclusion criteria
Exclusion criteria: 1. Symptomatic gastrointestinal bleedin 2. Patients with Inflammatory Bowel Disease, Peptic ulcer disease 3. History of gastrectomy or any recent intestinal surgery 4. Patients with marked constipation or severe gastrointestinal motility disorder. 5. Known patients with Hemochromatosis. 6. Patients diagnosed with chronic liver disease. 7. Serum Ferritin >= 1000 ng/ml or Transferrin saturation > 55% during initial screening. 8. Patients who had undergone parathyroidectomy. 9. Patient with diagnosis of acute kidney injury superimposed on chronic kidney disease. 10. Patients receiving inadequate/ irregular hemodialysis will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the serum phosphate Level at end of treatment between Ferric citrate and Sevelamer carbonateTimepoint: Comparison of the serum phosphate Level at the end of 12 weeks of treatment between Ferric citrate and Sevelamer carbonate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the change in serum phosphate Level from baseline to end of treatment between ferric citrate and sevelamer carbonate. 2. Comparison of the serum calcium level at end of treatment between ferric citrate and sevelamer carbonate. 3. Comparison of the calcium-phosphate product (CaXP) at end of treatment between ferric citrate and sevelamer carbonate. 4. Comparison of the iron status (S. Ferritin level and Transferrin saturation) at end of treatment between ferric citrate and sevelamer carbonate. 5. Comparison of the ESA dose at end of treatment between ferric citrate and sevelamer carbonate. 6. Comparison of the proportion of patients achieving the target Hemoglobin level (10-12 g/dL) at the end of treatment between ferric citrate and sevelamer carbonate. 7. Comparison of the serum iPTH Level at end of treatment between ferric citrate and sevelamer carbonate. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Minakshi Dhar
AIIMS, Rishikesh, Dehradun, Uttarakhand
Outcome results
None listed