Niacin and Endothelial Function in Early CKD

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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