End Stage Renal DiseasePhase 1NCT00880750
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
A Phase 1 study testing Lanthanum carbonate Granule Formulation and Lanthanum carbonate Chewable Tablets (Fosrenol) in people with End Stage Renal Disease, run by Shire at 1 site in United States.
Trial summary
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Lanthanum carbonate Granule Formulation and Lanthanum carbonate Chewable Tablets (Fosrenol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2009to 22 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 55 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 18-55 inclusive.
- Subject must be willing to comply with applicable contraceptive requirements of the protocol
- Female subjects must have a negative pregnancy test
- Ability to chew and or swallow doses of the investigational products as prescribed in the protocol.
- Ability to fully comply with all study procedures and restrictions, including consumption of all food provided while a resident in the CRC.
Who cannot join
- 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.
- Clinically significant abnormal serum phosphate levels, outside of normal limits.
- Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 7 days of first dose of investigational product.
- A known history of lactose intolerance or allergy to milk or other foods.
- Clinically significant or multiple allergies as determined by an Investigator.
- History of alcohol or other substance abuse within the last 6 months.
Show all 16Show 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.
- Female subjects who are pregnant (positive pregnancy test), lactating, or less than 90 days post-partum.
- Subjects that have previously been randomized in this study.
- 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 60 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.
- Plasma donation within 28 days prior to the first dose of the 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials, LLC
Cypress, California, 90630
About this study
Official title: A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.
- Conditions
- End Stage Renal Disease
- Being tested
- Lanthanum carbonate Granule Formulation, Lanthanum carbonate Chewable Tablets (Fosrenol)
- Keywords
- End stage Renal disease
- 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 carbonate Granule FormulationDrug
3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.)
Lanthanum carbonate Chewable Tablets (Fosrenol)Drug
Also called Fosrenol
3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)
| Study group | Role | What they receive |
|---|---|---|
| Lanthanum carbonate granules | Experimental | Lanthanum carbonate granulated formulation crossover to chewable tablet formulation Receives: Drug: Lanthanum carbonate Granule Formulation |
| Lanthanum carbonate chewable tablets (Fosrenol) | Experimental | Lanthanum carbonate chewable table formulation crossover to granulated formulation Receives: Drug: Lanthanum carbonate Chewable Tablets (Fosrenol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Phosphate Excretion 3-Day Average
Measured: Continuous collection over 3 days
Secondary outcomes (4)
Urinary Phosphate Excretion on Day 4
Measured: Continuous collection on Day 4
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate
Measured: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate
Measured: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate
Measured: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study start28 Jan 2009
- Primary completion22 Jun 2009
- Study completion22 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 (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880750
- Sponsor's protocol ID
- SPD405-127
- Status last verified
- Jun 2021
- First submitted
- 13 Apr 2009
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pierce D, Hossack S, Robinson A, Zhang P, Martin P. Assessment of pharmacodynamic equivalence and tolerability of lanthanum carbonate oral powder and tablet formulations: a single-center, randomized, open-label, 2-period crossover study in healthy subjects. Clin Ther. 2012 Jun;34(6):1290-1300.e2. doi: 10.1016/j.clinthera.2012.05.003. Epub 2012 May 31.
PubMed 22657252
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00880750
- Acronym / sponsor ID
- SPD405-127
- Conditions
- End Stage Renal Disease
- Keywords
- End stage Renal disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2009 (actual)
- Primary completion
- 22 Jun 2009 (actual)
- Study completion
- 22 Jun 2009 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 11 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanthanum carbonate granules | Experimental | Drug: Lanthanum carbonate Granule FormulationLanthanum carbonate granulated formulation crossover to chewable tablet formulation |
| Lanthanum carbonate chewable tablets (Fosrenol) | Experimental | Drug: Lanthanum carbonate Chewable Tablets (Fosrenol)Lanthanum carbonate chewable table formulation crossover to granulated formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to provide informed consent to participate in the study.
- Healthy volunteers, age 18-55 inclusive.
- Subject must be willing to comply with applicable contraceptive requirements of the protocol
- Female subjects must have a negative pregnancy test
- Ability to chew and or swallow doses of the investigational products as prescribed in the protocol.
Key exclusion criteria (16 listed)
- 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.
- Clinically significant abnormal serum phosphate levels, outside of normal limits.
- Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 7 days of first dose of investigational product.
- A known history of lactose intolerance or allergy to milk or other foods.
- Clinically significant or multiple allergies as determined by an Investigator.
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 carbonate Granule Formulation3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.) | Drug | Lanthanum carbonate granules |
| Lanthanum carbonate Chewable Tablets (Fosrenol)Also: Fosrenol3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.) | Drug | Lanthanum carbonate chewable tablets (Fosrenol) |
Primary outcome
Urinary Phosphate Excretion 3-Day Average
Time frame: Continuous collection over 3 days
4 secondary outcomes
Urinary Phosphate Excretion on Day 4
Time frame: Continuous collection on Day 4
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate
Time frame: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate
Time frame: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate
Time frame: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22657252Pierce D, Hossack S, Robinson A, Zhang P, Martin P. Assessment of pharmacodynamic equivalence and tolerability of lanthanum carbonate oral powder and tablet formulations: a single-center, randomized, open-label, 2-period crossover study in healthy subjects. Clin Ther. 2012 Jun;34(6):1290-1300.e2. doi: 10.1016/j.clinthera.2012.05.003. Epub 2012 May 31.
- 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 Granule Formulation and Lanthanum carbonate Chewable Tablets (Fosrenol) in people with End Stage Renal Disease, 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 6 inclusion and 16 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 11 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 11 Mar 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?
Urinary Phosphate Excretion 3-Day Average (time frame: Continuous collection over 3 days). 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 NCT00880750, which also lists 1 linked publication.
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 11 Jun 2021.