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

NCT ID: NCT01159054

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

This study has only one arm.

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

Group Type: EXPERIMENTAL

Extended Release Nicotinic Acid (Niaspan)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Extended Release Nicotinic Acid; Niaspan

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kambiz Zandi-Nejad, MD

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kambiz ZANDI-NEJAD, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

BWH/FH/DCI Outpatient Dialysis Unit

Boston, Massachusetts, United States

DCI Dialysis Unit-Somerville

Somerville, Massachusetts, United States

Countries

United States

Other Identifiers

2010P001049

Identifier Type: -

Identifier Source: org_study_id