Niacin and Endothelial Function in Early CKD

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00852969
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Niacin; Drug: Active Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Niacin	Drug: Niacin; 1000 mg tablets once per day; Other Names: Niaspan
Placebo Comparator: Placebo	Drug: Active Placebo; 100 mg Niacin tablets once per day

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in HDL-C From Baseline to 14 Weeks [14 weeks since baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Mark Sarnak, MD, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT00852969
• Other Study ID Numbers: 5R21DK077368; 5R21DK077368-02
• First Posted: Feb 27, 2009
• Last Update Posted: May 6, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Tufts Medical Center: Chronic Kidney Disease; Niacin; HDL; Endothelial Function
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Niacin

Study Results

Participant Flow

Recruitment Details	All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011
Pre-assignment Detail	There was no washout period. Patients receiving Niacin were excluded from the study.

Arm/Group Title	Niacin	Placebo
Arm/Group Description	Niacin : 1000 mg tablets once per day	Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	13
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Niacin	Placebo	Total
Arm/Group Description	Niacin : 1000 mg tablets once per day	Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 66.7%	13 86.7%	23 76.7%
>=65 years	5 33.3%	2 13.3%	7 23.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.1 (10.9)	50.4 (11.9)	54.2 (11.9)
Sex: Female, Male (Count of Participants)
Female	6 40%	11 73.3%	17 56.7%
Male	9 60%	4 26.7%	13 43.3%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin	Placebo
Arm/Group Description	Niacin : 1000 mg tablets once per day	Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Measure Participants	15	13
Mean (95% Confidence Interval) [absolute percent change]	3.07	1.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Niacin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.69
	Confidence Interval	(2-Sided) 95%; -10.79 to 7.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in HDL-C From Baseline to 14 Weeks
Time Frame	14 weeks since baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin	Placebo
Arm/Group Description	Niacin : 1000 mg tablets once per day	Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Measure Participants	15	15
Mean (95% Confidence Interval) [mg/dl]	5.22	2.74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Niacin, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.48
	Confidence Interval	(2-Sided) 95%; -7.20 to 2.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	During the trial up to 14 weeks
Arm/Group Title	Niacin		Placebo
Arm/Group Description	Niacin : 1000 mg tablets once per day		Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
All Cause Mortality
	Niacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Niacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Niacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/15 (66.7%)		5/15 (33.3%)
Gastrointestinal disorders
diarrhea	2/15 (13.3%)	2	0/15 (0%)	0
constipation	0/15 (0%)	0	5/15 (33.3%)	5
nausea	1/15 (6.7%)	1	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
joint pains	1/15 (6.7%)	1	0/15 (0%)	0
Skin and subcutaneous tissue disorders
flushing	10/15 (66.7%)	10	5/15 (33.3%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.