Comparison of Ferric Citrate and Sevelamer in the treatment of high phosphate level in patients with Chronic Kidney Disease

Not Applicable

• Conditions: Health Condition 1: N189- Chronic kidney disease, unspecified

• Registration Number: CTRI/2021/11/037748
• Lead Sponsor: il

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age > 18 years with eGFR < 60ml/min/1.73m2

2. Patients who are not taking phosphate binders with serum phosphate level > 6mg/dl and < 10mg/dl

3. Patients who had discontinued phosphate binders for > 2weeks with serum phosphate level > 6mg/dl and < 10mg/dl

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.Comparison of the change in serum phosphate Level from baseline to end of treatment between ferric citrate and sevelamer carbonate. <br/ ><br>2.Comparison of the serum calcium level at end of treatment between ferric citrate and sevelamer carbonate. <br/ ><br>3.Comparison of the calcium-phosphate product (CaXP) at end of treatment between ferric citrate and sevelamer carbonate. <br/ ><br>4.Comparison of the iron status (S. Ferritin level and Transferrin saturation) at end of treatment between ferric citrate and sevelamer carbonate. <br/ ><br>5.Comparison of the ESA dose at end of treatment between ferric citrate and sevelamer carbonate. <br/ ><br>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. <br/ ><br>7.Comparison of the serum iPTH Level at end of treatment between ferric citrate and sevelamer carbonate. <br/ ><br>Timepoint: 12 weeks