Kidney Failure, ChronicPhase 1NCT00875017

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

A Phase 1 study testing Lanthanum Carbonate and Sevelamer in people with Kidney Failure, Chronic, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: Lanthanum Carbonate and Sevelamer
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 20 Apr 2009to 16 Jun 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

West Coast Clinical Trials
Cypress, California, 90630

Other trials in United States

About this study

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

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).

Conditions: Kidney Failure, Chronic
Being tested: Lanthanum Carbonate, Sevelamer
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lanthanum CarbonateDrug
Also called Fosrenol
1 x 1000mg tablet
SevelamerDrug
Also called Renvela
3 x 800mg tablets

Study groups in NCT00875017
Study group	Role	What they receive
Meal + Lanthanum	Experimental	Not described Receives: Drug: Lanthanum Carbonate
Meal + Sevelamer	Active comparator	Not described Receives: Drug: Sevelamer
Meal Only	No intervention	Not described
Fasting	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 10 hours post-dose

Secondary outcomes (2)

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.
Measured: 10 hours post-dose
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).
Measured: 10 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 200916 Jun 2009

First posted3 Apr 2009 (estimated)
Study start20 Apr 2009
Primary completion16 Jun 2009
Study completion16 Jun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875017
Sponsor's protocol ID: SPD405-128
Status last verified: May 2021
First submitted: 22 Jan 2009
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21354682
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.
PubMed 24197066

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00875017
Acronym / sponsor ID: SPD405-128
Conditions: Kidney Failure, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 20 Apr 2009 (actual)
Primary completion: 16 Jun 2009 (actual)
Study completion: 16 Jun 2009 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 2 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Meal + Lanthanum	Experimental	Drug: Lanthanum Carbonate
Meal + Sevelamer	Active comparator	Drug: Sevelamer
Meal Only	No intervention	–
Fasting	No intervention	–

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lanthanum CarbonateAlso: Fosrenol1 x 1000mg tablet	Drug	Meal + Lanthanum
SevelamerAlso: Renvela3 x 800mg tablets	Drug	Meal + Sevelamer

Primary outcome

Net Phosphorous Absorption
Time frame: 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).

2 secondary outcomes

Net Phosphorous Binding
Time frame: 10 hours post-dose
Net Calcium Absorption
Time frame: 10 hours post-dose

Results and safety

Results posted to the registry on 2 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	5	3
Sequence 2	5	5
Sequence 3	5	4
Sequence 4	6	5
Sequence 5	5	4
Sequence 6	5	5

Primary outcome: Net Phosphorous Absorption

Time frame: 10 hours post-dose. Least squares mean (Standard Error). Unit: mg

Measure	Lanthanum Carbonate n = 18	Sevelamer Carbonate n = 18	Meal Only n = 18
Value	156.03 (14.161)	221.78 (14.112)	281.68 (14.112)

Lanthanum Carbonate vs Sevelamer Carbonate: Least Squares (LS) Mean Difference: -65.75 (95% CI -96.01 to -35.49), p <0.001, Mixed Models Analysis
Lanthanum Carbonate vs Meal Only: LS Mean Difference: -125.65 (95% CI -155.91 to -95.39), p <0.001, Mixed Models Analysis
Sevelamer Carbonate vs Meal Only: LS Mean Difference: -59.90 (95% CI -89.87 to -29.93), p <0.001, Mixed Models Analysis

Population analysed: Pharmacodynamic Set (PD) consists of subjects who provided all rectal effluent collections and completed all treatment periods. Subjects who vomited during any of the treatment periods were excluded from the PD set.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanthanum Carbonate	0 of 23 (0%)	0 of 23 (0%)	Not reported
Sevelamer Carbonate	0 of 24 (0%)	0 of 24 (0%)	Not reported
Meal Only	0 of 26 (0%)	3 of 26 (11.5%)	Not reported
Fasting	0 of 20 (0%)	3 of 20 (15%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21354682Martin 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.
Results publication: PubMed 24197066Behets 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.
FDA recall informationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lanthanum Carbonate and Sevelamer in people with Kidney Failure, Chronic, run by Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Phosphorous Absorption (time frame: 10 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00875017, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.