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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01159054
• Other study ID #: 2010P001049
• Status: Terminated
• Phase: N/A
• First received: July 7, 2010
• Last updated: May 28, 2014
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Dialysis
• Inflammation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in FDG-PET/CT dual scan score		6 months	No
Primary	Changes in hs-CRP level		6 monhts	No
Primary	Changes in IL-6 level		6 months	No
Secondary	Albumin level		6 months	No
Secondary	ESA dose requirement		6 months	No
Secondary	Hemoglobin level		6 months	No
Secondary	Rate of cardiovascular events		6 months	No
Secondary	Hemodialysis access stenosis/thrombosis		6 months	No
Secondary	Incidence of rises in liver function tests		6 months (checked monthly)	Yes