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NCT01560884 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb
A Phase 1 study of Safety and Phosphate Binding Capacity, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01560884: Completed Phase 1 study of Safety and Phosphate Binding Capacity, sponsored by Spectrum Pharmaceuticals.
NCT01560884 is a Phase 1 study of Safety and Phosphate Binding Capacity that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 32 participants, below the 125-participant average among 10 other Safety trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560884, a Phase 1 study of Safety and Phosphate Binding Capacity, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal failure. Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after treatment.
Primary Outcome
Efficacy will be evaluated by comparing difference in urine and fecal phosphorous excretion before and after treatment.
Conditions Studied
Interventions
- DRUG Renazorb 1500 mg/day
- DRUG Renazorb 3000 mg/day
- DRUG Renazorb 4500 mg/day
- DRUG Renazorb 6000 mg/day
Study Locations (1)
Maryland
- PAREXEL International - Baltimore Early Phase Clinical Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01560884 record still lists
NCT01560884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 125-participant average among 10 other Safety trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Safety appearing as the primary indexed condition, and to 4 interventions - of which Renazorb 1500 mg/day is the first listed.
NCT01560884 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01560884 about?
NCT01560884 is a clinical study titled "Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb". The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal failure. Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increas...
What is the current status of trial NCT01560884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-04. Estimated completion is 2012-09.
What conditions does trial NCT01560884 study?
This clinical trial studies the following conditions: Safety, Phosphate Binding Capacity.
What interventions are being tested in trial NCT01560884?
The interventions under investigation include: Renazorb 1500 mg/day (DRUG), Renazorb 3000 mg/day (DRUG), Renazorb 4500 mg/day (DRUG), Renazorb 6000 mg/day (DRUG).
Who is sponsoring clinical trial NCT01560884?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01560884 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01560884's enrollment target sits among peer trials
32 11th of 10 the lowest of 10 other Safety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Safety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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