Clinical trial NCT03451019: Different Effects of Non-calcium Phosphate Binders on Serum Calcium
Official title: Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease - mineral bone disorder, phosphate-binders
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2018-03-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the change of serum calcium for 24 hours after each drug
timeFrame: 3, 6, 12 and 24 hours after administration of each drug
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Department of Nephrology, Hypertension and Kidney Transplantation
Study officials:
affiliation: Medical University of Lodz
name: Michal Nowicki, Prof.MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makowka A, Nowicki M. Different Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Calcium Balance in Patients with Moderate to Advanced Chronic Kidney Disease. Ther Clin Risk Manag. 2021 Nov 2;17:1145-1151. doi: 10.2147/TCRM.S330649. eCollection 2021.