Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00732069
First received: August 6, 2008
Last updated: June 22, 2013
Last verified: June 2013
Results First Received: July 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: End Stage Renal Failure on Dialysis
Complication of Hemodialysis
Interventions: Drug: Placebo
Drug: Ramipril
Drug: Valsartan

  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
Recruitment started in September 2008 and ended in January 2010 in Vanderbilt outpatients Dialysis Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three consented participants were excluded because of hyperkalemia, hypotension and uncontrollable hypertension.They were enrolled but did not start medication and were considered screen failures. The participants required a washout period from either an agiotensin receptor blocker or an angiotensin converting enzyme inhibitor.

Reporting Groups
  Description
Placebo, Then Ramipril, Then Valsartan Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
Placebo, Valsartan, Then Ramipril Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
Ramipril, Then Placebo, Then Valsartan Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
Valsartan, Then Placebo, Then Ramipril Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
Ramipril, Valsartan, Then Placebo Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
Valsartan, Ramipril, Then Placebo Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.

Participant Flow for 5 periods

Period 1:   First Study Drug
    Placebo, Then Ramipril, Then Valsartan     Placebo, Valsartan, Then Ramipril     Ramipril, Then Placebo, Then Valsartan     Valsartan, Then Placebo, Then Ramipril     Ramipril, Valsartan, Then Placebo     Valsartan, Ramipril, Then Placebo  
STARTED     3     3     3     2     3     2  
COMPLETED     3     3     3     2     3     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Washout After First Study Drug
    Placebo, Then Ramipril, Then Valsartan     Placebo, Valsartan, Then Ramipril     Ramipril, Then Placebo, Then Valsartan     Valsartan, Then Placebo, Then Ramipril     Ramipril, Valsartan, Then Placebo     Valsartan, Ramipril, Then Placebo  
STARTED     3     3     3     2     3     2  
COMPLETED     2     3     3     2     3     2  
NOT COMPLETED     1     0     0     0     0     0  
Adverse Event                 1                 0                 0                 0                 0                 0  

Period 3:   Second Study Drug
    Placebo, Then Ramipril, Then Valsartan     Placebo, Valsartan, Then Ramipril     Ramipril, Then Placebo, Then Valsartan     Valsartan, Then Placebo, Then Ramipril     Ramipril, Valsartan, Then Placebo     Valsartan, Ramipril, Then Placebo  
STARTED     2     3     3     2     3     2  
COMPLETED     2     3     3     2     3     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 4:   Washout After Second Study Drug
    Placebo, Then Ramipril, Then Valsartan     Placebo, Valsartan, Then Ramipril     Ramipril, Then Placebo, Then Valsartan     Valsartan, Then Placebo, Then Ramipril     Ramipril, Valsartan, Then Placebo     Valsartan, Ramipril, Then Placebo  
STARTED     2     3     3     2     3     2  
COMPLETED     2     3     3     2     3     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Third Study Drug
    Placebo, Then Ramipril, Then Valsartan     Placebo, Valsartan, Then Ramipril     Ramipril, Then Placebo, Then Valsartan     Valsartan, Then Placebo, Then Ramipril     Ramipril, Valsartan, Then Placebo     Valsartan, Ramipril, Then Placebo  
STARTED     2     3     3     2     3     2  
COMPLETED     2     3     3     2     3     2  
NOT COMPLETED     0     0     0     0     0     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.
No text entered.

Reporting Groups
  Description
All Study Participants After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  50.5  ± 3.1  
Gender  
[units: participants]
 
Female     8  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Interleukin 1 Beta   [ Time Frame: During dialysis after one week of study drug ]

2.  Secondary:   F2-Isoprostanes   [ Time Frame: During dialysis after one week of study drug ]


  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
No text entered.


  More Information
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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: Dr. Nancy J. Brown
Organization: Vanderbilt University
phone: 615-343-8701
e-mail: nancy.j.brown@vanderbilt.edu


Publications of Results:

Responsible Party: Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00732069     History of Changes
Other Study ID Numbers: Fibrinolysis in Dialysis, R01HL065193-08A2
Study First Received: August 6, 2008
Results First Received: July 18, 2012
Last Updated: June 22, 2013
Health Authority: United States: Institutional Review Board