Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3

This study has been terminated.
(insufficient enrollment and retention)
Sponsor:
Collaborators:
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00878969
First received: April 8, 2009
Last updated: January 18, 2016
Last verified: January 2016
Results First Received: November 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Oxidative Stress
Endothelial Dysfunction
Interventions: Drug: valsartan (ARB)
Drug: ramipril (ACE inhibitor)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at the Vanderbilt University Medical Center and at the University of Washington between January 2010 and June 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There is a 3-week period between enrollment and assignment to treatment group. This "washout" period is to ensure that no blood pressure medicines (ARBs or ACE inhibitors) are left in the body. Although 123 subjects were enrolled, only 78 were assigned to a treatment group (45 subjects were screen failures).

Reporting Groups
  Description
Valsartan 80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
Ramipril 2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
Placebo matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months

Participant Flow:   Overall Study
    Valsartan     Ramipril     Placebo  
STARTED     25     27     26  
COMPLETED     10     12     15  
NOT COMPLETED     15     15     11  
Physician Decision                 5                 3                 2  
Withdrawal by Subject                 1                 6                 3  
kidney transplant                 2                 3                 2  
Adverse Event                 3                 1                 2  
Lost to Follow-up                 2                 1                 0  
Protocol Violation                 2                 0                 0  
Death                 0                 0                 2  
Pregnancy                 0                 1                 0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Valsartan 80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
Ramipril 2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
Placebo matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
Total Total of all reporting groups

Baseline Measures
    Valsartan     Ramipril     Placebo     Total  
Number of Participants  
[units: participants]
  25     27     26     78  
Age  
[units: years]
Mean (Standard Deviation)
  53  (13)     53  (13)     49  (9)     52  (12)  
Gender  
[units: participants]
       
Female     11     8     9     28  
Male     14     19     17     50  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     3     6     1     10  
Not Hispanic or Latino     22     21     25     68  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     13     16     15     44  
White     10     7     9     26  
More than one race     0     0     0     0  
Unknown or Not Reported     2     4     2     8  
Region of Enrollment  
[units: participants]
       
United States     25     27     26     78  



  Outcome Measures

1.  Primary:   Interleukin-6 (IL-6)   [ Time Frame: baseline and 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: T. Alp Ikizler, MD
Organization: Vanderbilt University
phone: 615-343-6104
e-mail: alp.ikizler@vanderbilt.edu



Responsible Party: Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00878969     History of Changes
Other Study ID Numbers: Fibrinolysis in Dialysis Aim 3
R01HL065193-08A2 ( US NIH Grant/Contract Award Number )
Study First Received: April 8, 2009
Results First Received: November 20, 2015
Last Updated: January 18, 2016
Health Authority: United States: Institutional Review Board