Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Sevelamer Hydrochloride; Drug: Lanthanum Carbonate

• Registration Number: NCT03451019
• Lead Sponsor: Medical University of Lodz

Brief Summary

Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.

Detailed Description

Recent experimental studies have shown that a non-calcium based phosphate binder sevelamer hydrochloride can increase intestinal calcium absorption in contrast to lanthanum carbonate. It is unknown whether such the difference may have an effect on bone metabolism and/or modify the development of vascular calcification in patients with chronic kidney disease. The aim of the study was to compare the effect of a single dose of 1000 mg of lanthanum carbonate with 2,4 mg of sevelamer hydrochloride on serum and urine calcium following an oral load of 5 g of calcium carbonate given with a meal with standardized phosphate content.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-23
• Study Start: 2018-03-01
• Study First Posted: 2018-03-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• adult patient
• with eGFR ≤45 ml/min

Exclusion Criteria

• hypercalcemia (>ULN),
• serum phosphate >1.2 times normal value
• calcium-phosphate disturbances not associated with CKD, e.g. Paget disease, osteoporosis, any bone fracture within 6 months before study, multiple myeloma or any neoplastic disease, liver or biliary tract disease, primary hyperparathyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
lanthanum carbonate	Sevelamer Hydrochloride	the subject receive a single dose of 1.0 g
sevelamer hydrochloride	Sevelamer Hydrochloride	the subject receive a single dose of 2,4 g
sevelamer hydrochloride	Lanthanum Carbonate	the subject receive a single dose of 2,4 g
lanthanum carbonate	Lanthanum Carbonate	the subject receive a single dose of 1.0 g

Primary Outcome Measures

Name	Time	Method
the change of serum calcium for 24 hours after each drug	3, 6, 12 and 24 hours after administration of each drug	absolute change vs baseline and 24h area under the curve

Trial Locations

Locations (1)

Department of Nephrology, Hypertension and Kidney Transplantation; 🇵🇱 Łódź, Poland