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

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ClinicalTrials.gov Identifier: NCT01159054
Recruitment Status : Terminated (The funding source is not going to fund this anymore. Only two subjects completed the study therefore meaningful analysis not possible.)
First Posted : July 9, 2010
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Dialysis
Cardiovascular Disease
Atherosclerosis
Inflammation
Intervention Drug: Extended Release Nicotinic Acid (Niaspan)
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Period Title: Overall Study
Started 22
Completed 2
Not Completed 20
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  63.6%
>=65 years
8
  36.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
58.9
(25 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Changes in FDG-PET/CT Dual Scan Score
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Changes in Hs-CRP Level
Hide Description Change in hs-CRP level before and after treatment in each subject
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 subjects completed the study. Power for further analysis was not met.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: mg/L
Average Pre-Treatment
18.465
(9.09 to 27.84)
Average Post-Treatment
26.395
(8.76 to 44.03)
3.Primary Outcome
Title Changes in IL-6 Level
Hide Description Change in IL-6 level before and after treatment in each subject
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 subjects completed the study. Further analysis not done because power was not met.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: pg/mL
Average Pre-Treatment
5.1254
(1.962 to 8.287)
Average Post-Treatment
14.8375
(3.152 to 26.523)
4.Secondary Outcome
Title Albumin Level
Hide Description Pre and Post levels.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 subjects completed the study. Further analysis was not done because power was not met.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: g/dL
Average Pre-Treatment
3.9
(3.9 to 3.9)
Average Post-Treatment
4.05
(3.8 to 4.3)
5.Secondary Outcome
Title ESA (Erythorpoietic Stimulating Agent) Dose Requirement
Hide Description Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Hemoglobin Level
Hide Description Pre and Post Levels
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 2 subjects completed the study. Further analysis was not done because power was not met.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: g/dL
Average Pre-Treatment
11.6
(10.9 to 12.3)
Average Post-Treatment
10.15
(9.3 to 11)
7.Secondary Outcome
Title Rate of Cardiovascular Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected from the medical record due to early termination of the study.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Hemodialysis Access Stenosis/Thrombosis
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected from the medical record due to early termination of the study.
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description:

Blood sample and scan results to be compared before and after intervention in each subject.

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.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
0
Time Frame 6 months (the time between the first and the second scan)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group (One Arm Only Study)
Hide Arm/Group Description

Blood sample and scan results to be compared before and after intervention in each subject.

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.

All-Cause Mortality
Treatment Group (One Arm Only Study)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment Group (One Arm Only Study)
Affected / at Risk (%) # Events
Total   1/22 (4.55%)    
Cardiac disorders   
Atrial Fibrillation * [1]  1/22 (4.55%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One subject with pre-existing atrial fibrillation developed another episode of atrial fibrillation and was taken off the study out of abundance of caution and was reported to IRB.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Group (One Arm Only Study)
Affected / at Risk (%) # Events
Total   2/22 (9.09%)    
Gastrointestinal disorders   
GI upset *  1/22 (4.55%)  1
Skin and subcutaneous tissue disorders   
Flushing *  2/22 (9.09%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kambiz Zandi-Nejad
Organization: Brigham and Women's Hospital
Phone: 617-732-6660 ext 34769 page
EMail: kzandinejad@partners.org
Layout table for additonal information
Responsible Party: Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01159054    
Other Study ID Numbers: 2010P001049
First Submitted: July 7, 2010
First Posted: July 9, 2010
Results First Submitted: March 3, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017