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Calcium Acetate
1 for Hyperphosphatemia
Phase 1
Waitlist Available
Led By Antoinette A. Pragalos, MD
Research Sponsored by Fresenius Medical Care North America
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.
Eligible Conditions
- Hyperphosphatemia
- High Phosphate Levels
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: 3Experimental Treatment1 Intervention
Calcium Citrate 950 mg Caplets
Group II: 1Experimental Treatment1 Intervention
Calcium Acetate Oral Solution 667 mg per 5 mL
Group III: 2Active Control1 Intervention
Calcium Acetate 667 mg Gelcaps
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium Citrate 950 mg Caplets
2008
Completed Phase 1
~50
Calcium acetate
FDA approved
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Fresenius Medical Care North AmericaLead Sponsor
39 Previous Clinical Trials
78,128 Total Patients Enrolled
2 Trials studying Hyperphosphatemia
271 Patients Enrolled for Hyperphosphatemia
Antoinette A. Pragalos, MDPrincipal InvestigatorCommunity Research
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