NCT03451019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

February 20, 2018

Last Update Submit

July 26, 2021

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease - mineral bone disorder, phosphate-binders

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

sevelamer hydrochloride

ACTIVE COMPARATOR

the subject receive a single dose of 2,4 g

Drug: Sevelamer HydrochlorideDrug: Lanthanum Carbonate

lanthanum carbonate

ACTIVE COMPARATOR

the subject receive a single dose of 1.0 g

Drug: Sevelamer HydrochlorideDrug: Lanthanum Carbonate

Interventions

Sevelamer HydrochlorideDRUG

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
lanthanum carbonatesevelamer hydrochloride
Lanthanum CarbonateDRUG

Single oral doses of lanthanum (1000 mg)

Also known as: Fosrenol
lanthanum carbonatesevelamer hydrochloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patient
  • with eGFR ≤45 ml/min

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Hypertension and Kidney Transplantation

Lodz, 90-153, Poland

Location

Related Publications (1)

  • 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: 34754193DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicChronic Kidney Disease-Mineral and Bone Disorder

Interventions

Sevelamerlanthanum carbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Michal Nowicki, Prof.MD PhD

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 1, 2018

Study Start

March 1, 2018

Primary Completion

December 15, 2020

Study Completion

December 30, 2020

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)