HyperphosphatemiaPhase 2NCT00834301
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
A Phase 2 study testing Oral Multivitamin in people with Hyperphosphatemia and Inflammation, run by Nephrian at 1 site in United States.
Trial summary
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperphosphatemia, Inflammation, Renal Disease
- What is being tested?
- Oral Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections
- Serum phosphorous level > 5 mg/dl
- Stable phosphate binder regimen for 2 week prior to enrollment
- Stable dose of Vitamin D for 4 weeks prior to enrollment
- Stable calcimimetic dose for 4 week prior to enrollment
Who cannot join
- patients who are pregnant
- patients who have pre existing thrombocytopenia defined as a platelet count of <100 x 109/L
- abnormal LFTs
- baseline CRP > 15 g/dl
- known sensitivity to any of the active ingredients
- patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months
- are currently taking any immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Simi Valley Dialysis Center
Simi Valley, California, 93063
Kant Tucker, MD, 805-433-7500
Kant Tucker, MD
About this study
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.
- Conditions
- Hyperphosphatemia, Inflammation, Renal Disease
- Being tested
- Oral Multivitamin
- Keywords
- End Stage Renal Disease, Inflammation
- Medical subject headings
- Hyperphosphatemia, Inflammation, Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral MultivitaminDietary supplement
Oral Multivitamin
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Dietary Supplement: Oral Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.
Measured: 8 weeks
Secondary outcomes (1)
To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nephrian
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ray Chow, PhD, Study director, Nephrian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834301
- Sponsor's protocol ID
- N0801
- Status last verified
- Feb 2009
- First submitted
- 2 Feb 2009
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT00834301
- Acronym / sponsor ID
- N0801
- Conditions
- Hyperphosphatemia, Inflammation, Renal Disease
- Keywords
- End Stage Renal Disease, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- NephrianIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 3 Feb 2009 (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.
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Dietary Supplement: Oral Multivitamin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections
- Serum phosphorous level > 5 mg/dl
- Stable phosphate binder regimen for 2 week prior to enrollment
- Stable dose of Vitamin D for 4 weeks prior to enrollment
- Stable calcimimetic dose for 4 week prior to enrollment
Key exclusion criteria (7 listed)
- patients who are pregnant
- patients who have pre existing thrombocytopenia defined as a platelet count of <100 x 109/L
- abnormal LFTs
- baseline CRP > 15 g/dl
- known sensitivity to any of the active ingredients
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 |
|---|---|---|
| Oral MultivitaminOral Multivitamin | Dietary supplement | Treatment Arm |
Primary outcome
To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.
Time frame: 8 weeks
1 secondary outcome
To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
Ray Chow, PhD study director
Nephrian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Multivitamin in people with Hyperphosphatemia and Inflammation, run by Nephrian 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: status not confirmed, as of the sponsor's last update on 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population. (time frame: 8 weeks). 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 3 Feb 2009.