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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875017
• Other study ID #: SPD405-128
• Status: Completed
• Phase: Phase 1
• Start date: April 20, 2009
• Est. completion date: June 16, 2009

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 16, 2009
• Est. primary completion date: June 16, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Lanthanum Carbonate
1 x 1000mg tablet
• Sevelamer
3 x 800mg tablets

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.00219.201 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Net Phosphorous Binding	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.	10 hours post-dose
Secondary	Net Calcium Absorption	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).	10 hours post-dose

External Links

•   FDA recall information
•   FDA-approved label