Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Sevelamer Hydrochloride
* Drug: Lanthanum Carbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective randomized open-label study included 34 patients with CKD. Single oral dose of one of phosphate binders (sevelamer or lanthanum) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal. Serum calcium, phosphate and parathormone were measured at 0, 3, 6, 12, 24 hours after each medication. Bone alkaline phosphatase (BAP), sclerostin, calcitriol and FGF-23 were measured at 0, 12 and 24 hours after dose. Calcium and phosphate were measured in 24h urine collections after each drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sevelamer hydrochloride<br>the subject receive a single dose of 2,4 g | Drug: Sevelamer Hydrochloride<br>* Single oral doses of lanthanum (1000 mg) or Sevelamer (2400 mg) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal<br>* Other names: Renagel;Drug: Lanthanum Carbonate<br>* Single oral doses of lanthanum (1000 mg)<br>* Other names: Fosrenol;|
| Active Comparator: lanthanum carbonate<br>the subject receive a single dose of 1.0 g | Drug: Sevelamer Hydrochloride<br>* Single oral doses of lanthanum (1000 mg) or Sevelamer (2400 mg) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal<br>* Other names: Renagel;Drug: Lanthanum Carbonate<br>* Single oral doses of lanthanum (1000 mg)<br>* Other names: Fosrenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of serum calcium for 24 hours after each drug | absolute change vs baseline and 24h area under the curve | 3, 6, 12 and 24 hours after administration of each drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease - mineral bone disorder, phosphate-binders