Different Effects of Non-calcium Phosphate Binders on Serum Calcium

NCT03451019 — Phase 4, Completed, 34 participants, Medical University of Lodz

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03451019
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	34 (Actual)
Sponsor	Medical University of Lodz (Other); collaborators: Shire
Conditions	Chronic Kidney Disease
Interventions	Sevelamer Hydrochloride, Lanthanum Carbonate (Drug)
Dates	start 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 in Poland

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
sevelamer hydrochloride	Active comparator	Drug: Sevelamer Hydrochloride; Drug: Lanthanum Carbonate	the subject receive a single dose of 2,4 g
lanthanum carbonate	Active comparator	Drug: Sevelamer Hydrochloride; Drug: Lanthanum Carbonate	the subject receive a single dose of 1.0 g

Sevelamer Hydrochloride (Drug), also known as Renagel: 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 (Drug), also known as Fosrenol: Single oral doses of lanthanum (1000 mg)

+Outcome measures

Primary outcomes

the change of serum calcium for 24 hours after each drug [3, 6, 12 and 24 hours after administration of each drug]: absolute change vs baseline and 24h area under the curve

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Nephrology, Hypertension and Kidney Transplantation	Lodz	Poland

+Publications

Results publication: 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. PMID 34754193

+Investigators

Michal Nowicki, Prof.MD PhD, Principal investigator, Medical University of Lodz

My Notes

Public

To Read Reading Read