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NCT03451019 Clinical Trial

Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03451019
Other study ID # S-L2018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 1, 2018
Est. completion date December 30, 2020

Study information
Verified date July 2021
Source Medical University of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date December 30, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• Lanthanum Carbonate
Single oral doses of lanthanum (1000 mg)

Locations
Country Name City State
Poland Department of Nephrology, Hypertension and Kidney Transplantation Lódz

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Lodz Shire

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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