Hyperphosphatemia in Chronic Kidney DiseasePhase 1NCT00458289
Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate
A Phase 1 study testing Lanthanum carbonate (chewed vs. crushed) in people with Hyperphosphatemia in Chronic Kidney Disease, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperphosphatemia in Chronic Kidney Disease
- What is being tested?
- Lanthanum carbonate (chewed vs. crushed)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women at least 18 years of age
- No clinically significant abnormal findings on clinical laboratory evaluation and medical history
- Within 15% of ideal body weight for height and build according to the Metropolitan Life tables5
- Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative pregnancy test
- Women who are sexually active must be using effective means of contraception
Who cannot join
- History of dysphagia or swallowing disorders
- Clinically significant illness within 3 months of study enrollment
- Concomitant use of medication that might interact with lanthanum carbonate
- Pregnant or intends to become pregnant within 30 days of completing the study
- Breast feeding
- Alcohol or controlled substance abuse
- Use of an investigational agent within 30 days of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago, Dept of Pharmacy Practice
Chicago, Illinois, 60612
About this study
Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia.
Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them.
The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.
- Being tested
- Lanthanum carbonate (chewed vs. crushed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum carbonate (chewed vs. crushed)Drug
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | P-containing meal alone |
| 2 | Active comparator | P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate Receives: Drug: Lanthanum carbonate (chewed vs. crushed) |
| 3 | Active comparator | P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder Receives: Drug: Lanthanum carbonate (chewed vs. crushed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorous concentration
Measured: Hourly from time=0-8 h after administration of meal and drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperphosphatemia in Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Alan Lau, University of Illinois Chicago
- Investigators
- Alan H Lau, Pharm.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458289
- Sponsor's protocol ID
- 2006-0530
- Status last verified
- Dec 2019
- First submitted
- 6 Apr 2007
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate
- ClinicalTrials.gov ID
- NCT00458289
- Acronym / sponsor ID
- 2006-0530
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia.
Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them.
The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –P-containing meal alone |
| 2 | Active comparator | Drug: Lanthanum carbonate (chewed vs. crushed)P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate |
| 3 | Active comparator | Drug: Lanthanum carbonate (chewed vs. crushed)P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women at least 18 years of age
- No clinically significant abnormal findings on clinical laboratory evaluation and medical history
- Within 15% of ideal body weight for height and build according to the Metropolitan Life tables5
- Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative pregnancy test
- Women who are sexually active must be using effective means of contraception
Key exclusion criteria (7 listed)
- History of dysphagia or swallowing disorders
- Clinically significant illness within 3 months of study enrollment
- Concomitant use of medication that might interact with lanthanum carbonate
- Pregnant or intends to become pregnant within 30 days of completing the study
- Breast feeding
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 (chewed vs. crushed)single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder | Drug | 2, 3 |
Primary outcome
Serum phosphorous concentration
Time frame: Hourly from time=0-8 h after administration of meal and drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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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.
Alan H Lau, Pharm.D. principal investigator
University of Illinois Chicago
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 (chewed vs. crushed) in people with Hyperphosphatemia in Chronic Kidney Disease, run by University of Illinois Chicago 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 5 inclusion and 7 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 20 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum phosphorous concentration (time frame: Hourly from time=0-8 h after administration of meal and drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2019.