Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Niacin and Endothelial Function in Early CKD

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00852969
First received: February 26, 2009
Last updated: April 3, 2014
Last verified: April 2014
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Interventions: Drug: Niacin
Drug: Active Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no washout period. Patients receiving Niacin were excluded from the study.

Reporting Groups
  Description
Niacin Niacin : 1000 mg tablets once per day
Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance

Participant Flow:   Overall Study
    Niacin     Placebo  
STARTED     15     15  
COMPLETED     15     13  
NOT COMPLETED     0     2  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These were the number of individuals who agreed to be randomized for the study

Reporting Groups
  Description
Niacin Niacin : 1000 mg tablets once per day
Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Total Total of all reporting groups

Baseline Measures
    Niacin     Placebo     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     13     23  
>=65 years     5     2     7  
Age  
[units: years]
Mean ± Standard Deviation
  58.1  ± 10.9     50.4  ± 11.9     54.2  ± 11.9  
Gender  
[units: participants]
     
Female     6     11     17  
Male     9     4     13  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Flow Mediated Dilation From Baseline   [ Time Frame: 14 weeks since baseline ]

2.  Secondary:   Change in HDL-C From Baseline to 14 Weeks   [ Time Frame: 14 weeks since baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide 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.


Results Point of Contact:  
Name/Title: Mark Sarnak, MD
Organization: Tufts Medical Center
phone: 617 636-1182
e-mail: msarnak@tuftsmedicalcenter.org


No publications provided


Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00852969     History of Changes
Other Study ID Numbers: 5R21DK077368, 5R21DK077368-02
Study First Received: February 26, 2009
Results First Received: November 27, 2013
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board