Clinical Trials Directory

Trials / Completed

CompletedNCT03451019

Different Effects of Non-calcium Phosphate Binders on Serum Calcium

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Medical University of Lodz · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSevelamer HydrochlorideSingle 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
DRUGLanthanum CarbonateSingle oral doses of lanthanum (1000 mg)

Timeline

Start date
2018-03-01
Primary completion
2020-12-15
Completion
2020-12-30
First posted
2018-03-01
Last updated
2021-07-27

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT03451019. Inclusion in this directory is not an endorsement.