Niacin and Endothelial Function in Early CKD

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Niacin; Drug: Active Placebo

• Registration Number: NCT00852969
• Lead Sponsor: Tufts Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-11-27
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-03
• Last Update Submitted: 2014-04-03
• Results First Posted: 2014-05-06
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niacin	Niacin	-
Placebo	Active Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in the Flow Mediated Dilation From Baseline	14 weeks since baseline	Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks

Secondary Outcome Measures

Name	Time	Method
Change in HDL-C From Baseline to 14 Weeks	14 weeks since baseline

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States