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

NCT01159054 | Terminated Results

• 1 other identifier: 2010P001049
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief 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

Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation

Outcome Measures

Primary Outcomes (3)

• Changes in FDG-PET/CT Dual Scan Score

  6 months

• Changes in Hs-CRP Level

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

  6 months

• Changes in IL-6 Level

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

  6 months

Secondary Outcomes (6)

• Albumin Level

  6 months

• ESA (Erythorpoietic Stimulating Agent) Dose Requirement

  6 months

• Hemoglobin Level

  6 months

• Rate of Cardiovascular Events

  6 months

• Hemodialysis Access Stenosis/Thrombosis

  6 months

Study Arms (1)

This study has only one arm.

EXPERIMENTAL

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

Drug: Extended Release Nicotinic Acid (Niaspan)

Interventions

Extended Release Nicotinic Acid (Niaspan) DRUG

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

This study has only one arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

BWH/FH/DCI Outpatient Dialysis Unit

Boston, Massachusetts, 02130, United States

Location

DCI Dialysis Unit-Somerville

Somerville, Massachusetts, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Inflammation

Interventions

Niacin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Kambiz Zandi-Nejad
• Organization: Brigham and Women's Hospital

kzandinejad@partners.org

617-732-6660

Study Officials

• Kambiz ZANDI-NEJAD, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Locations

US (3)