Chronic Kidney DiseasePhase 4NCT00852969
Niacin and Endothelial Function in Early CKD
A Phase 4 study testing Niacin in people with Chronic Kidney Disease, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)
- HDL-cholesterol <50 for men and <55 for women
- If taking a statin, stable dose for past one month
- Glucose <200 mg/dL and HbA1c <9%
- Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry
Who cannot join
- Hospitalization within prior 3 months
- Any of the following conditions:
- uncontrolled peptic ulcer disease
- active liver disease OR abnormal SGOT/SGPT
- history of adverse reaction to niacin
- contra-indication to aspirin
Show all 11Show fewer
- concurrent fibrate therapy
- history of gout
- serum phosphorus levels below 2.7mg/dl
- Nursing
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.
- Conditions
- Chronic Kidney Disease
- Being tested
- Niacin, Active Placebo
- Keywords
- Chronic Kidney Disease, Niacin, HDL, Endothelial Function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinDrug
Also called Niaspan
1000 mg tablets once per day
Active PlaceboDrug
100 mg Niacin tablets once per day
| Study group | Role | What they receive |
|---|---|---|
| Niacin | Active comparator | Not described Receives: Drug: Niacin |
| Placebo | Placebo comparator | Not described Receives: Drug: Active Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Flow Mediated Dilation From Baseline
Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks
Measured: 14 weeks since baseline
Secondary outcomes (1)
Change in HDL-C From Baseline to 14 Weeks
Measured: 14 weeks since baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Sarnak, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852969
- Sponsor's protocol ID
- 5R21DK077368
- Other IDs
- 5R21DK077368-02
- Status last verified
- Apr 2014
- First submitted
- 26 Feb 2009
- Last updated
- 6 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
- ClinicalTrials.gov ID
- NCT00852969
- Acronym / sponsor ID
- 5R21DK077368
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Niacin, HDL, Endothelial Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 6 May 2014
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 this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niacin | Active comparator | Drug: Niacin |
| Placebo | Placebo comparator | Drug: Active Placebo |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)
- HDL-cholesterol <50 for men and <55 for women
- If taking a statin, stable dose for past one month
- Glucose <200 mg/dL and HbA1c <9%
- Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry
Key exclusion criteria (11 listed)
- Hospitalization within prior 3 months
- Any of the following conditions:
- Nursing
- Pregnancy
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 |
|---|---|---|
| NiacinAlso: Niaspan1000 mg tablets once per day | Drug | Niacin |
| Active Placebo100 mg Niacin tablets once per day | Drug | Placebo |
Primary outcome
Change in the Flow Mediated Dilation From Baseline
Time frame: 14 weeks since baseline
Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks
1 secondary outcome
Change in HDL-C From Baseline to 14 Weeks
Time frame: 14 weeks since baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Sarnak, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Niacin in people with Chronic Kidney Disease, run by Tufts Medical Center 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 11 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 6 May 2014. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Flow Mediated Dilation From Baseline (time frame: 14 weeks since baseline). 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 6 May 2014.