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Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Sevelamer Hydrochloride
Lanthanum Carbonate
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease - mineral bone disorder, phosphate-binders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nephrology, Hypertension and Kidney Transplantation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sevelamer hydrochloride

lanthanum carbonate

Arm Description

the subject receive a single dose of 2,4 g

the subject receive a single dose of 1.0 g

Outcomes

Primary Outcome Measures

the change of serum calcium for 24 hours after each drug
absolute change vs baseline and 24h area under the curve

Secondary Outcome Measures

Full Information

First Posted
February 20, 2018
Last Updated
July 26, 2021
Sponsor
Medical University of Lodz
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT03451019
Brief Title
Different Effects of Non-calcium Phosphate Binders on Serum Calcium
Official Title
Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz
Collaborators
Shire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease - mineral bone disorder, phosphate-binders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sevelamer hydrochloride
Arm Type
Active Comparator
Arm Description
the subject receive a single dose of 2,4 g
Arm Title
lanthanum carbonate
Arm Type
Active Comparator
Arm Description
the subject receive a single dose of 1.0 g
Intervention Type
Drug
Intervention Name(s)
Sevelamer Hydrochloride
Other Intervention Name(s)
Renagel
Intervention Description
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
Intervention Name(s)
Lanthanum Carbonate
Other Intervention Name(s)
Fosrenol
Intervention Description
Single oral doses of lanthanum (1000 mg)
Primary Outcome Measure Information:
Title
the change of serum calcium for 24 hours after each drug
Description
absolute change vs baseline and 24h area under the curve
Time Frame
3, 6, 12 and 24 hours after administration of each drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Nowicki, Prof.MD PhD
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Hypertension and Kidney Transplantation
City
Łódź
ZIP/Postal Code
90-153
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34754193
Citation
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.
Results Reference
derived

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Different Effects of Non-calcium Phosphate Binders on Serum Calcium

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