DialysisNCT01159054

Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid

A study testing Extended Release Nicotinic Acid (Niaspan) in people with Dialysis and Cardiovascular Disease, run by Brigham and Women's Hospital at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dialysis, Cardiovascular Disease, Atherosclerosis
What is being tested?: Extended Release Nicotinic Acid (Niaspan)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 3 sitesUnited States
Study dates: Jul 2010to Dec 2014
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A signed consent form;
Male or Female, 18 years or older;
Diagnosed with ESRD, on maintenance hemodialysis for at least six (6) months;
Subject must be able to understand and provide informed consent;
No known contraindications to therapy with nicotinic acid;
Female subjects of childbearing potential must be willing to be on an acceptable form of birth control for the duration of the study and for two month after they have stopped taking the study drug.

Who cannot join

Any patient with a medical condition or taking any medications that would be contraindicated with the use of extended release niacin, such as active peptic ulcer disease;
History of severe allergic reactions to the study medication;
History of active infection or acute gouty attack within 2 weeks prior to enrollment;
Known serological positivity for HIV, HBsAg, or HCV Ab;
HbA1C > 9;
Total CK of more than three times of the upper limit of normal;

Show all 14Show fewer

Elevation of liver function tests at time of entry (AST and/or ALT > 2 times the upper limit of normal);
History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;
History of malignancy except adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
History of an inflammatory disease such as SLE, rheumatoid arthritis or ulcerative colitis;
Patients currently on pharmacological doses of nicotinic acid;
Patients receiving chronic anti-inflammatory therapy;
Patients with average baseline hs-CRP levels of > 20 mg/L or < 1 mg/L;
Patients in whom FDG-PET/CT dual scans are contraindicated (e.g., pregnant patients or those with severe allergy to IV contrast; a pregnancy test will be performed in each female subject between 18 and 45 years of age prior to each scan)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
BWH/FH/DCI Outpatient Dialysis Unit
Boston, Massachusetts, 02130
DCI Dialysis Unit-Somerville
Somerville, Massachusetts

Other trials in United States

About this study

Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular disease including atherosclerotic cardiovascular disease. This, at least in part, is due to the chronic inflammatory status usually seen in these patients. Here we try to see if treatment with extended release nicotinic acid (Niaspan) can reduce their overall inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).

Conditions: Dialysis, Cardiovascular Disease, Atherosclerosis, Inflammation
Being tested: Extended Release Nicotinic Acid (Niaspan)
Medical subject headings: Cardiovascular Diseases, Atherosclerosis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extended Release Nicotinic Acid (Niaspan)Drug
Also called Extended Release Nicotinic Acid, Niaspan
Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Study groups in NCT01159054
Study group	Role	What they receive
This study has only one arm.	Experimental	Blood sample and scan results to be compared before and after intervention in each subject. Receives: Drug: Extended Release Nicotinic Acid (Niaspan)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in FDG-PET/CT Dual Scan Score
Measured: 6 months
Changes in Hs-CRP Level
Change in hs-CRP level before and after treatment in each subject
Measured: 6 months
Changes in IL-6 Level
Change in IL-6 level before and after treatment in each subject
Measured: 6 months

Secondary outcomes (6)

Albumin Level
Pre and Post levels.
Measured: 6 months
ESA (Erythorpoietic Stimulating Agent) Dose Requirement
Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.
Measured: 6 months
Hemoglobin Level
Pre and Post Levels
Measured: 6 months
Rate of Cardiovascular Events
Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.
Measured: 6 months
Hemodialysis Access Stenosis/Thrombosis
Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.
Measured: 6 months
Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).
The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)
Measured: 6 months (checked monthly)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Dec 2014

First posted9 Jul 2010 (estimated)
Study startJul 2010
Primary completionDec 2014
Study completionDec 2014

Why it stopped: The funding source is not going to fund this anymore. Only two subjects completed the study therefore meaningful analysis not possible.

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 DialysisStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01159054
Sponsor's protocol ID: 2010P001049
Status last verified: May 2017
First submitted: 7 Jul 2010
Last updated: 28 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All Dialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
ClinicalTrials.gov ID: NCT01159054
Acronym / sponsor ID: 2010P001049
Conditions: Dialysis, Cardiovascular Disease, Atherosclerosis, Inflammation
Study type: Interventional
Recruitment status: TerminatedReason stopped: The funding source is not going to fund this anymore. Only two subjects completed the study therefore meaningful analysis not possible.
Enrolment: 22 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: Jul 2010
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 9 Jul 2010 (estimated)
Results: Posted 28 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
This study has only one arm.	Experimental	Drug: Extended Release Nicotinic Acid (Niaspan)Blood sample and scan results to be compared before and after intervention in each subject.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

A signed consent form;
Male or Female, 18 years or older;
Diagnosed with ESRD, on maintenance hemodialysis for at least six (6) months;
Subject must be able to understand and provide informed consent;
No known contraindications to therapy with nicotinic acid;

Key exclusion criteria (14 listed)

Any patient with a medical condition or taking any medications that would be contraindicated with the use of extended release niacin, such as active peptic ulcer disease;
History of severe allergic reactions to the study medication;
History of active infection or acute gouty attack within 2 weeks prior to enrollment;
Known serological positivity for HIV, HBsAg, or HCV Ab;
HbA1C > 9;

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
Extended Release Nicotinic Acid (Niaspan)Also: Extended Release Nicotinic Acid, NiaspanSubjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.	Drug	This study has only one arm.

Primary outcome

Changes in FDG-PET/CT Dual Scan Score
Time frame: 6 months
Changes in Hs-CRP Level
Time frame: 6 months
Change in hs-CRP level before and after treatment in each subject
Changes in IL-6 Level
Time frame: 6 months
Change in IL-6 level before and after treatment in each subject

6 secondary outcomes

Albumin Level
Time frame: 6 months
ESA (Erythorpoietic Stimulating Agent) Dose Requirement
Time frame: 6 months
Hemoglobin Level
Time frame: 6 months
Rate of Cardiovascular Events
Time frame: 6 months
Hemodialysis Access Stenosis/Thrombosis
Time frame: 6 months
Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).
Time frame: 6 months (checked monthly)

Results and safety

Results posted to the registry on 28 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group (One Arm Only Study)	22	2

Primary outcome: Changes in FDG-PET/CT Dual Scan Score

Time frame: 6 months

Measure	Treatment Group (One Arm Only Study) n = 0
Value	0

Population analysed: Analysis of images for this outcome measure was not done given than only 2 subjects had completed the study at the time of the study early termination and closure (per funding source)

Primary outcome: Changes in Hs-CRP Level

Time frame: 6 months. Mean (Full Range). Unit: mg/L

Measure	Treatment Group (One Arm Only Study) n = 2
Average Pre-Treatment	18.465 (9.09 to 27.84)
Average Post-Treatment	26.395 (8.76 to 44.03)

Population analysed: Only 2 subjects completed the study. Power for further analysis was not met.

Primary outcome: Changes in IL-6 Level

Time frame: 6 months. Mean (Full Range). Unit: pg/mL

Measure	Treatment Group (One Arm Only Study) n = 2
Average Pre-Treatment	5.1254 (1.962 to 8.287)
Average Post-Treatment	14.8375 (3.152 to 26.523)

Population analysed: Only 2 subjects completed the study. Further analysis not done because power was not met.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months (the time between the first and the second scan). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group (One Arm Only Study)	1 of 22 (4.5%)	2 of 22 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dialysis

Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
RecruitingObservational study
Il Registro Italiano di Dialisi Pediatrica (RIDP) - Italian Registry of Pediatric Dialysis
Dialysis, Kidney Transplantation
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

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.

Kambiz ZANDI-NEJAD, MD principal investigator

Brigham and Women's Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Extended Release Nicotinic Acid (Niaspan) in people with Dialysis and Cardiovascular Disease, run by Brigham and Women's Hospital at 3 sites 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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2017). 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?

Changes in FDG-PET/CT Dual Scan Score (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT01159054.

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 28 Jun 2017.