Niacin and Endothelial Function in Early CKD

Chronic Kidney Disease Clinical Trial

Official title:

Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852969
• Other study ID #: 5R21DK077368
• Secondary ID: 5R21DK077368-02
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2009
• Last updated: April 3, 2014
• Start date: August 2008
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Niacin
1000 mg tablets once per day
• Active Placebo
100 mg Niacin tablets once per day

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Flow Mediated Dilation From Baseline	Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks	14 weeks since baseline	No
Secondary	Change in HDL-C From Baseline to 14 Weeks		14 weeks since baseline	No