Niacin and Endothelial Function in Early CKD

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)

• HDL-cholesterol <50 for men and <55 for women

• If taking a statin, stable dose for past one month

• Glucose <200 mg/dL and HbA1c <9%

• Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry

Exclusion Criteria:

• Hospitalization within prior 3 months

• Any of the following conditions:

• uncontrolled peptic ulcer disease

• active liver disease OR abnormal SGOT/SGPT

• history of adverse reaction to niacin

• contra-indication to aspirin

• concurrent fibrate therapy

• history of gout

• serum phosphorus levels below 2.7mg/dl

• Nursing

• Pregnancy