Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-12-30

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.

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sevelamer hydrochloride

the subject receive a single dose of 2,4 g

Group Type ACTIVE_COMPARATOR

Sevelamer Hydrochloride

Intervention Type DRUG

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

Lanthanum Carbonate

Intervention Type DRUG

Single oral doses of lanthanum (1000 mg)

lanthanum carbonate

the subject receive a single dose of 1.0 g

Group Type ACTIVE_COMPARATOR

Sevelamer Hydrochloride

Intervention Type DRUG

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

Lanthanum Carbonate

Intervention Type DRUG

Single oral doses of lanthanum (1000 mg)

Interventions

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Sevelamer Hydrochloride

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

Intervention Type DRUG

Lanthanum Carbonate

Single oral doses of lanthanum (1000 mg)

Intervention Type DRUG

Other Intervention Names

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Renagel Fosrenol

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No