NCT02237534

Brief Summary

The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

8.6 years

First QC Date

September 9, 2014

Last Update Submit

February 24, 2021

Conditions

Renal Insufficiency, ChronicHyperphosphatemiaBone Diseases, Metabolic

Keywords

LanthanumCalcium CarbonateVascular Calcification

Outcome Measures

Primary Outcomes (1)

  • Coronary artery calcification score

    1 year

Secondary Outcomes (15)

  • Endothelial function

    3 months

  • Serum bone metabolic markers

    3 months

  • Serum bone metabolic markers

    1 year

  • Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time

    Up to 1 year

  • Estimated glomerular filtration rate over time

    Up to 1 year

  • +10 more secondary outcomes

Other Outcomes (3)

  • Micro RNA array

    1 year

  • Hypercalcemia

    Up to 1 year

  • Hypocalcemia

    Up to 1 year

Study Arms (2)

Calcium carbonate

ACTIVE COMPARATOR

Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration \<4.5 mg/dL. Maximum dose is 3,000 mg/day.

Drug: Calcium Carbonate

Lanthanum carbonate

EXPERIMENTAL

Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration \<4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.

Drug: Lanthanum carbonate

Interventions

Lanthanum carbonateDRUG
Also known as: FOSRENOL®
Lanthanum carbonate
Calcium CarbonateDRUG
Calcium carbonate

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
  • With written informed consent

You may not qualify if:

  • History of cardiac surgery
  • With coronary artery stent
  • Polycystic kidney disease
  • Hypothyroidism
  • On treatment with lanthanum carbonate
  • History of admission within 3 months
  • History of ileus
  • Severe liver dysfunction
  • Severe gastrointestinal dysfunction
  • Allergy to lanthanum carbonate or calcium carbonate
  • Pregnant or breastfeeding women
  • Judged as ineligible by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHyperphosphatemiaBone Diseases, MetabolicVascular Calcification

Interventions

lanthanum carbonateCalcium Carbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBone DiseasesMusculoskeletal DiseasesCalcinosisCalcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Takayuki Hamano, MD, PhD

    Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endowed chair

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 11, 2014

Study Start

September 1, 2014

Primary Completion

March 31, 2023

Study Completion

September 1, 2023

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

JP(1)