Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb
NCT ID: NCT01560884
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2012-04-30
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Following a screening period and evaluation of eligibility criteria, subjects will be admitted to the clinical research unit. From Day 1 to Day 10 subjects will be placed on a controlled phosphate diet (approved by a qualified dietician). From Day 1 to Day 5 (each day), 24 hour urine and feces will be collected at each voiding and pooled in separate containers for baseline phosphorus content. On Days 6 to 10, the subjects will receive SPI-014 or placebo within 15 minutes after each of the 3 main meals (see table below). From the morning of Day 8 to the morning of Day 13, 24 hour urine and feces will be collected for each day to determine phosphorus content. Subjects will be discharged on Day 13 and return 7 days later for an End-of-Study Visit on Day 20.
Starting dose will be 1500 mg/day. All safety data, including laboratory tests and adverse events, will be reviewed prior to escalation to the next cohort. After completion of first cohort, if no grades 3 AEs (vomiting and nausea) are observed in the first cohort on Day 20,Confidential 24 treatment of the second cohort begins. Similarly, third and fourth cohort will follow after the completion of the second and third cohort respectively.
Subjects will be admitted to the clinical research unit on Day -1 and remain at the clinical research unit until Day 13. From Day 1 to Day 10, subjects will consume a phosphate-controlled diet designed to provide 37.5 mmol (1200 mg) of elemental phosphorus per day (3 meals and 1 snack). The mean phosphorus contents of the meals are 12.1 mmol (387 mg), 8.6 mmol (275 mg), 12.0 mmol (416 mg), and 2.6 mmol (83 mg) for breakfast, lunch, dinner, and snack, respectively. With breakfast, the majority of the phosphorus is administered in milk. With the other meals phosphorus is primarily administered in solid food. During this 10-day treatment period subjects will be required to ingest all meals in their entirety.
The primary endpoint is phosphate binding capacity of SPI-014 as judged by levels of phosphorus in feces and urine. Phosphate excretion in urine is expected to go down and fecal excretion is expected to go up after treatment with SPI-014. Safety assessments are periodic physical examinations with vital sign measurements, safety laboratory tests, ECGs, AEs, and serious adverse events (SAEs).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group B
Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo
Renazorb 3000 mg/day
Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo
Group C
Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo
Renazorb 4500 mg/day
Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo
Group D
Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo
Renazorb 6000 mg/day
Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo
Group A
Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo
Renazorb 1500 mg/day
Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Renazorb 1500 mg/day
Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo
Renazorb 3000 mg/day
Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo
Renazorb 4500 mg/day
Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo
Renazorb 6000 mg/day
Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ronald Goldwater
Role: PRINCIPAL_INVESTIGATOR
PAREXEL, Harbor Hospital Center, Baltimore, MD 21225
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PAREXEL International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pergola PE, Joy MS, Garsd A, Hasal SJ, Khare A, Reddy G, Gupta P, Finn WF. Safety and Phosphate-Binding Capacity of Oxylanthanum Carbonate in Healthy Volunteers. Clin Transl Sci. 2025 Jan;18(1):e70116. doi: 10.1111/cts.70116.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPI-RZB-11-101
Identifier Type: -
Identifier Source: org_study_id