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

Phase 1

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Drug: Lanthanum Carbonate; Drug: Sevelamer

• Registration Number: NCT00875017
• Lead Sponsor: Shire

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Study Start: 2009-04-20
• Primary Completion: 2009-06-16
• Study Completion: 2009-06-16
• Results First Submitted: 2010-03-03
• Results First Submitted QC: 2010-05-26
• Results First Posted: 2010-07-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meal + Lanthanum	Lanthanum Carbonate	-
Meal + Sevelamer	Sevelamer	-

Primary Outcome Measures

Name	Time	Method
Net Phosphorous Absorption	10 hours post-dose	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

Name	Time	Method
Net Phosphorous Binding	10 hours post-dose	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	10 hours post-dose	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).

Trial Locations

Locations (1)

West Coast Clinical Trials; 🇺🇸 Cypress, California, United States