HyperphosphatemiaPhase 1/2NCT00508885
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
A Phase 1/2 study testing Niacinamide in people with Hyperphosphatemia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Niacinamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2007
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Capable of giving informed consent
- Duration of peritoneal dialysis > 3 months
- Dose of phosphate binder(s) stable over previous 2 week period
- Plasma phosphours > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment
Who cannot join
- Pregnancy
- Known liver disease
- Active peptic ulcer disease
- Treatment with carbamazepine
- Intolerance to niacinamide or niacin
- Current medication regimen including niacin or niacinamide > 100 mg daily
- Planned or expected surgical procedure in the next 4 months
- Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels > 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus.
- Conditions
- Hyperphosphatemia
- Being tested
- Niacinamide, Placebo
- Keywords
- hyperphosphatemia, niacinamide, ESRD, peritoneal dialysis, renal osteodystrophy
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinamideDrug
Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily Receives: Drug: Niacinamide |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo
Measured: 8 weeks
Secondary outcomes (1)
The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus
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 posted30 Jul 2007 (estimated)
- Study startOct 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Daniel O Young, MD, Principal investigator, Washington University, Renal Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508885
- Sponsor's protocol ID
- HSC 06-0462
- Status last verified
- Jul 2007
- First submitted
- 26 Jul 2007
- Last updated
- 30 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086Young DO, Cheng SC, Delmez JA, Coyne DW. The effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients. Perit Dial Int. 2009 Sep-Oct;29(5):562-7.
PubMed 19776051
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00508885
- Acronym / sponsor ID
- HSC 06-0462
- Conditions
- Hyperphosphatemia
- Keywords
- hyperphosphatemia, niacinamide, ESRD, peritoneal dialysis, renal osteodystrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Jul 2007 (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.
Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels > 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NiacinamideNiacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Capable of giving informed consent
- Duration of peritoneal dialysis > 3 months
- Dose of phosphate binder(s) stable over previous 2 week period
- Plasma phosphours > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment
Key exclusion criteria (8 listed)
- Pregnancy
- Known liver disease
- Active peptic ulcer disease
- Treatment with carbamazepine
- Intolerance to niacinamide or niacin
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 |
|---|---|---|
| NiacinamideNiacinamide 250 mg twice daily titrated up to 750 mg twice daily | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo
Time frame: 8 weeks
1 secondary outcome
The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus
Time frame: 8 weeks
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 30 Jul 2007.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
- Derived from this study: PubMed 19776051Young DO, Cheng SC, Delmez JA, Coyne DW. The effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients. Perit Dial Int. 2009 Sep-Oct;29(5):562-7.
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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.
Daniel O Young, MD principal investigator
Washington University, Renal Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Niacinamide in people with Hyperphosphatemia, run by Washington University School of Medicine 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 8 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 30 Jul 2007. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
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?
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508885, which also lists 2 linked publications.
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 30 Jul 2007.