Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Medical University of Lodz

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Lanthanum Carbonate; Drug: Sevelamer Hydrochloride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03451019

S-L2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

sevelamer hydrochloride

Active Comparator group

Description:

the subject receive a single dose of 2,4 g

Treatment:

Drug: Sevelamer Hydrochloride

Drug: Lanthanum Carbonate

lanthanum carbonate

Active Comparator group

Description:

the subject receive a single dose of 1.0 g

Treatment:

Drug: Sevelamer Hydrochloride

Drug: Lanthanum Carbonate