Niacin and Endothelial Function in Early CKD

NCT00852969 | Completed Phase 4 Results DMC

• 2 other identifiers: 5R21DK0773685R21DK077368-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Niacin; HDL; Endothelial Function

Outcome Measures

Primary Outcomes (1)

• Change in the Flow Mediated Dilation From Baseline

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

  14 weeks since baseline

Secondary Outcomes (1)

• Change in HDL-C From Baseline to 14 Weeks

  14 weeks since baseline

Study Arms (2)

Niacin

ACTIVE COMPARATOR

Drug: Niacin

Placebo

PLACEBO COMPARATOR

Drug: Active Placebo

Interventions

Niacin DRUG

1000 mg tablets once per day

Also known as: Niaspan

Niacin

Active Placebo DRUG

100 mg Niacin tablets once per day

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Niacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Mark Sarnak, MD
• Organization: Tufts Medical Center

msarnak@tuftsmedicalcenter.org

617 636-1182

Study Officials

• Mark Sarnak, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: August 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 6, 2014
• Results First Posted: May 6, 2014

Record last verified: 2014-04

Locations

US (1)