A Phase 4 interventional study of Sevelamer Hydrochloride and Lanthanum Carbonate in Chronic Kidney Disease, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Medical University of Lodz · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
the subject receive a single dose of 2,4 g
Drug: Sevelamer Hydrochloride · Drug: Lanthanum Carbonate
the subject receive a single dose of 1.0 g
Drug: Sevelamer Hydrochloride · Drug: Lanthanum Carbonate
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
Also known as: Renagel
Single oral doses of lanthanum (1000 mg)
Also known as: Fosrenol
the change of serum calcium for 24 hours after each drug
absolute change vs baseline and 24h area under the curve
Time frame: 3, 6, 12 and 24 hours after administration of each drug
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Lodz