HyperphosphatemiaPhase 1NCT00742820
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
A Phase 1 study testing Calcium Acetate Oral Solution 667 mg per 5 mL, Calcium Acetate 667 mg GelCaps and Calcium Citrate 950 mg Caplets in people with Hyperphosphatemia, run by Fresenius Medical Care North America at 1 site in United States.
Trial summary
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Calcium Acetate Oral Solution 667 mg per 5 mL, Calcium Acetate 667 mg GelCaps and Calcium Citrate 950 mg Caplets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Ages: 18-75 years
- Serum Calcium level 8.6-10.2 mg/dL
- 25 vitamin D level 20-100 ng/mL
- 1, 25 dihydroxy vitamin D level 6-62 pg/mL
- Fasting glucose level of 65-99 mg/dL (min 8 hr fast)
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- iPTH level of 10-65 pg/mL
- Serum phosphorous level of 2.5-4.5 mg/dL
- Albumin level of 3.6-5.1 g/dL
- Sodium level of 135-146 mEq/L
- Potassium level of 3.5-5.3 mEq/L
- Negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study
- No clinically significant abnormalities on electrocardiogram (ECG) reading as determined by the INVESTIGATOR
- No clinically significant abnormalities on liver function tests
- No clinically significant abnormalities on CBC and coagulation studies
- No clinically significant abnormalities on kidney function (eGFR using serum creatinine)
- BMI between 18.5-30
- Subjects must agree not to consume alcohol while in the treatment phase of the study
Who cannot join
- Women who are pregnant or breast feeding
- Malignancy except squamous cell carcinoma of the skin
- Documented current acute or chronic disease
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Myocardial infarction within 6 months of study Day 0
- Parathyroidectomy within 6 months of study Day 0
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- Gastrointestinal disorder associated with impaired absorption of oral medications
- Inability to swallow tablets or tolerate calcium acetate oral solution
- Hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy
- Concurrent antibiotic treatment
- Any concurrent investigational treatment within 30 days of screening
- Unable or unwilling to comply fully with the protocol
- Diuretic therapy such as Thiazides, Furosemide (INN) or frusemide (former BAN) within one month before screening
- Subjects taking over-the-counter (OTC) or prescribed phosphorous or calcium containing supplements
- Subjects testing positive for drugs of abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, 3-Arm, Open Label, Cross-Over Bioequivalence Study Comparing Liquid PhosLo vs. PhosLo Gelcaps Using Calcium Citrate as a Positive Control in Healthy Volunteers
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
- Conditions
- Hyperphosphatemia
- Being tested
- Calcium Acetate Oral Solution 667 mg per 5 mL, Calcium Acetate 667 mg GelCaps, Calcium Citrate 950 mg Caplets
- Keywords
- bioequivalence
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Acetate Oral Solution 667 mg per 5 mLDrug
Drug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
Calcium Acetate 667 mg GelCapsDrug
Drug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses.
Calcium Citrate 950 mg CapletsDietary supplement
Drug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Calcium Acetate Oral Solution 667 mg per 5 mL Receives: Drug: Calcium Acetate Oral Solution 667 mg per 5 mL |
| 2 | Active comparator | Calcium Acetate 667 mg Gelcaps Receives: Drug: Calcium Acetate 667 mg GelCaps |
| 3 | Other | Calcium Citrate 950 mg Caplets Receives: Dietary Supplement: Calcium Citrate 950 mg Caplets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Phosphate
Measured: 24 hrs
Urinary Calcium
Measured: 24 hrs
Secondary outcomes (3)
Serum Calcium
Measured: 24 hrs
Urinary Phosphate
Measured: 24 hrs
Serum insulin and glucose
Measured: 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antoinette A. Pragalos, MD, Principal investigator, Community Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742820
- Sponsor's protocol ID
- LP-RTG-01-01
- Status last verified
- Feb 2009
- First submitted
- 26 Aug 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, 3-Arm, Open Label, Cross-Over Bioequivalence Study Comparing Liquid PhosLo vs. PhosLo Gelcaps Using Calcium Citrate as a Positive Control in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00742820
- Acronym / sponsor ID
- LP-RTG-01-01
- Conditions
- Hyperphosphatemia
- Keywords
- bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Aug 2008 (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.
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Calcium Acetate Oral Solution 667 mg per 5 mLCalcium Acetate Oral Solution 667 mg per 5 mL |
| 2 | Active comparator | Drug: Calcium Acetate 667 mg GelCapsCalcium Acetate 667 mg Gelcaps |
| 3 | Other | Dietary Supplement: Calcium Citrate 950 mg CapletsCalcium Citrate 950 mg Caplets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed and dated informed consent form
- Ages: 18-75 years
- Serum Calcium level 8.6-10.2 mg/dL
- 25 vitamin D level 20-100 ng/mL
- 1, 25 dihydroxy vitamin D level 6-62 pg/mL
Key exclusion criteria (15 listed)
- Women who are pregnant or breast feeding
- Malignancy except squamous cell carcinoma of the skin
- Documented current acute or chronic disease
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Myocardial infarction within 6 months of study Day 0
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 |
|---|---|---|
| Calcium Acetate Oral Solution 667 mg per 5 mLDrug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses | Drug | 1 |
| Calcium Acetate 667 mg GelCapsDrug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses. | Drug | 2 |
| Calcium Citrate 950 mg CapletsDrug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses | Dietary supplement | 3 |
Primary outcome
Serum Phosphate
Time frame: 24 hrs
Urinary Calcium
Time frame: 24 hrs
3 secondary outcomes
Serum Calcium
Time frame: 24 hrs
Urinary Phosphate
Time frame: 24 hrs
Serum insulin and glucose
Time frame: 6 hrs
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 9 Feb 2009.
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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.
Antoinette A. Pragalos, MD principal investigator
Community Research
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 Calcium Acetate Oral Solution 667 mg per 5 mL, Calcium Acetate 667 mg GelCaps and Calcium Citrate 950 mg Caplets in people with Hyperphosphatemia, run by Fresenius Medical Care North America 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 18 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 9 Feb 2009. 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 Phosphate (time frame: 24 hrs). The study lists 2 primary outcomes in all. 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 9 Feb 2009.