TerminatedNCT01159054Updated Jun 28, 2017Results posted

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

An interventional study of Extended Release Nicotinic Acid (Niaspan) in Dialysis, Cardiovascular Disease and Atherosclerosis, sponsored by Brigham and Women's Hospital. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated

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

Phase: Not applicable
Study type: Interventional
Enrollment: 22
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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 studied

Dialysis
Cardiovascular Disease
Atherosclerosis
Inflammation

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In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

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Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
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)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 22 participants (actual)

Study arms

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

Interventions

DrugExtended 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.
Also known as: Extended Release Nicotinic Acid, Niaspan

What researchers measure

Primary outcomes

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

Secondary outcomes

Albumin Level
Pre and Post levels.
Time frame: 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.
Time frame: 6 months
Hemoglobin Level
Pre and Post Levels
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 6 months (checked monthly)

Results

Posted Jun 28, 2017

Participant flow

Participant flow — Overall Study
Milestone	Treatment Group (One Arm Only Study)
Started	22
Completed	2
Not completed	20

Outcome measures

PrimaryChanges in FDG-PET/CT Dual Scan Score

Time frame:: 6 months

Changes in FDG-PET/CT Dual Scan Score
Measure	Treatment Group (One Arm Only Study)
Changes in FDG-PET/CT Dual Scan Score	0

PrimaryChanges in Hs-CRP Level

Change in hs-CRP level before and after treatment in each subject

Time frame:: 6 months
Reported as:: Mean · mg/L

Changes in Hs-CRP Level
mg/L	Treatment Group (One Arm Only Study)
Average Pre-Treatment	18.465 (9.09 to 27.84)
Average Post-Treatment	26.395 (8.76 to 44.03)

PrimaryChanges in IL-6 Level

Change in IL-6 level before and after treatment in each subject

Time frame:: 6 months
Reported as:: Mean · pg/mL

Changes in IL-6 Level
pg/mL	Treatment Group (One Arm Only Study)
Average Pre-Treatment	5.1254 (1.962 to 8.287)
Average Post-Treatment	14.8375 (3.152 to 26.523)

SecondaryAlbumin Level

Pre and Post levels.

Time frame:: 6 months
Reported as:: Mean · g/dL

Albumin Level
g/dL	Treatment Group (One Arm Only Study)
Average Pre-Treatment	3.9 (3.9 to 3.9)
Average Post-Treatment	4.05 (3.8 to 4.3)

SecondaryESA (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.

Time frame:: 6 months

ESA (Erythorpoietic Stimulating Agent) Dose Requirement
Measure	Treatment Group (One Arm Only Study)
ESA (Erythorpoietic Stimulating Agent) Dose Requirement	0

SecondaryHemoglobin Level

Pre and Post Levels

Time frame:: 6 months
Reported as:: Mean · g/dL

Hemoglobin Level
g/dL	Treatment Group (One Arm Only Study)
Average Pre-Treatment	11.6 (10.9 to 12.3)
Average Post-Treatment	10.15 (9.3 to 11)

SecondaryRate 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.

Time frame:: 6 months

Rate of Cardiovascular Events
Measure	Treatment Group (One Arm Only Study)
Rate of Cardiovascular Events	0

SecondaryHemodialysis 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.

Time frame:: 6 months

Hemodialysis Access Stenosis/Thrombosis
Measure	Treatment Group (One Arm Only Study)
Hemodialysis Access Stenosis/Thrombosis	0

SecondaryNumber 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)

Time frame:: 6 months (checked monthly)
Reported as:: Number · Participants

Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).
Participants	Treatment Group (One Arm Only Study)
Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).	0

Adverse events

Collected over 6 months (the time between the first and the second scan). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment Group (One Arm Only Study)	—	1/22 (4.5%)	2/22 (9.1%)

Most frequent serious events

Most frequent serious events
Event	Treatment Group (One Arm Only Study)
Atrial FibrillationCardiac disorders	1/22

Most frequent other events

Most frequent other events
Event	Treatment Group (One Arm Only Study)
FlushingSkin and subcutaneous tissue disorders	2/22
GI upsetGastrointestinal disorders	1/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Treatment Group (One Arm Only Study)
<=18 years	0
Between 18 and 65 years	14
>=65 years	8

Age, Continuous
Age, Continuous(years)	Treatment Group (One Arm Only Study)
Mean	58.9 (25 to 89)

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment Group (One Arm Only Study)
Female	11
Male	11

Region of Enrollment
Region of Enrollment(participants)	Treatment Group (One Arm Only Study)
United States	22

Study locations

3 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01159054
Lead sponsor: Brigham and Women's Hospital
Responsible party: Kambiz Zandi-Nejad, MD (Instructor in Medicine, Brigham and Women's Hospital) — Principal investigator
First posted: Jul 9, 2010
Start date: Jul 2010
Primary completion: Dec 2014
Completion: Dec 2014
Results posted: Jun 28, 2017
Last update: Jun 28, 2017

Study contacts

Kambiz ZANDI-NEJAD, MD

principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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