NCT00875017

Brief Summary

The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

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

January 22, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

April 20, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 2, 2010

Completed
Last Updated

June 15, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

January 22, 2009

Results QC Date

March 3, 2010

Last Update Submit

May 27, 2021

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Net Phosphorous Absorption

    Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting).

    10 hours post-dose

Secondary Outcomes (2)

  • Net Phosphorous Binding

    10 hours post-dose

  • Net Calcium Absorption

    10 hours post-dose

Study Arms (4)

Meal + Lanthanum

EXPERIMENTAL
Drug: Lanthanum Carbonate

Meal + Sevelamer

ACTIVE COMPARATOR
Drug: Sevelamer

Meal Only

NO INTERVENTION

Fasting

NO INTERVENTION

Interventions

Lanthanum CarbonateDRUG

1 x 1000mg tablet

Also known as: Fosrenol
Meal + Lanthanum
SevelamerDRUG

3 x 800mg tablets

Also known as: Renvela
Meal + Sevelamer

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to provide informed consent to participate in the study.
  • Healthy volunteers, age 19-45 inclusive.
  • Subject must be willing to comply with applicable contraceptive requirements of the protocol
  • Female subjects must have a negative pregnancy test
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation.
  • Body Mass Index (BMI) between 20.0 and 29.9kg/m² inclusive.
  • Serum 1.25 dihydroxy vitamin D3 \>30pg/mL.
  • Ability to chew or swallow a dose of the investigational products and mannitol solution as prescribed in the protocol.
  • Ability and willingness to fast for up to 24 hours.

You may not qualify if:

  • Current or recurrent disease that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.
  • Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  • Significant illness within 2 weeks of the first dose of investigational product.
  • Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 14 days of first dose of investigational product.
  • Known or suspected intolerance or hypersensitivity to the investigational product(s) or mannitol solution, closely related compounds or any of the stated ingredients.
  • History of alcohol or other substance abuse within the last year.
  • A positive screen for alcohol or drugs of abuse.
  • Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day.
  • A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.
  • Use of tobacco in any form or other nicotine-containing products in any form. Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product.
  • Routine consumption of more than two units of caffeine per day or subjects who experience caffeine withdrawal headaches.
  • Donation of blood or blood products within 60 days prior to receiving the first dose of investigational product.
  • Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.
  • An inability to follow a standardized diet and/or meal schedule, as required during the study.
  • Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

Related Publications (2)

  • Martin P, Wang P, Robinson A, Poole L, Dragone J, Smyth M, Pratt R. Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study. Am J Kidney Dis. 2011 May;57(5):700-6. doi: 10.1053/j.ajkd.2010.11.028. Epub 2011 Feb 26.

    PMID: 21354682RESULT

  • Behets GJ, Dams G, Damment SJ, Martin P, De Broe ME, D'Haese PC. Differences in gastrointestinal calcium absorption after the ingestion of calcium-free phosphate binders. Am J Physiol Renal Physiol. 2014 Jan 1;306(1):F61-7. doi: 10.1152/ajprenal.00219.2013. Epub 2013 Nov 6.

    PMID: 24197066RESULT

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

lanthanum carbonateSevelamer

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

April 3, 2009

Study Start

April 20, 2009

Primary Completion

June 16, 2009

Study Completion

June 16, 2009

Last Updated

June 15, 2021

Results First Posted

July 2, 2010

Record last verified: 2021-05

Locations

US(1)