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OpenTrials
Completed

NCT Number: NCT00852969

Niacin and Endothelial Function in Early CKD

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

niacin

Drug

1000 mg tablets once per day

Other names: Niaspan

Active placebo

Drug

100 mg Niacin tablets once per day

Primary outcomes

  1. Change in the Flow Mediated Dilation From Baseline

    Time frame: 14 weeks since baseline

    Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks

Secondary outcomes

  1. Change in HDL-C From Baseline to 14 Weeks

    Time frame: 14 weeks since baseline

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2009
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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