Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00875017
First received: January 22, 2009
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Lanthanum Carbonate
Drug: Sevelamer
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Phase I, One-dose, One-meal, Balance Study Comparing the Absorption of Dietary Phosphorus When Administering FOSRENOL® (Lanthanum Carbonate) or RENVELA® (Sevelamer Carbonate) in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Net Phosphorous Absorption [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Net Phosphorous Binding [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]

    Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only.

    Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only.


  • Net Calcium Absorption [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]

    Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting).

    Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting).

    Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting).



Enrollment: 31
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meal + Lanthanum Drug: Lanthanum Carbonate
1 x 1000mg tablet
Other Name: Fosrenol
Active Comparator: Meal + Sevelamer Drug: Sevelamer
3 x 800mg tablets
Other Name: Renvela
No Intervention: Meal Only
No Intervention: Fasting

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00875017

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Shire
  More Information

Additional Information:
Publications:
Martin P, Wang P, Robinson A, et al. Comparison of Dietary Phosphate Absorption After Single Doses of Lanthanum Carbonate and Sevelamer Carbonate in Healthy Volunteers: A Balance Study. American Journal of Kidney Diseases 57(5):700-706, May 2011.

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00875017     History of Changes
Other Study ID Numbers: SPD405-128
Study First Received: January 22, 2009
Results First Received: March 3, 2010
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014