Niacin and Endothelial Function in Early CKD

Tufts University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Active Placebo; Drug: Niacin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00852969

5R21DK077368

5R21DK077368-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Niacin

Active Comparator group

Treatment:

Drug: Niacin

Placebo

Placebo Comparator group

Treatment:

Drug: Active Placebo