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Measurement of Kidney Blood Flow and Oxygen Levels by MRI

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01318967
First Posted: March 21, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
Results First Submitted: December 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Chronic Kidney Disease
Interventions: Drug: Furosemide
Other: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Furosemide

With and without furosemide

Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.


Participant Flow:   Overall Study
    Furosemide
STARTED   10 
COMPLETED   10 
NOT COMPLETED   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
Furosemide

With and without furosemide

Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.


Baseline Measures
   Furosemide 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  80.0% 
>=65 years      2  20.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  60.0% 
Male      4  40.0% 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Measurement of Renal Blood Flow of the Kidney by the PAH Method   [ Time Frame: Renal blood flow is estimated over 1 hour by PAH ]

2.  Secondary:   Measurement of Regional Blood Oxygenation by MRI   [ Time Frame: One measure after furosemide (day 1) ]


  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:  
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: Michael Rocco, MD
Organization: Wake Forest School of Medicine
phone: 336-716-4650
e-mail: mrocco@wfubmc.edu



Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01318967     History of Changes
Other Study ID Numbers: 0537GCRC
First Submitted: March 18, 2011
First Posted: March 21, 2011
Results First Submitted: December 8, 2014
Results First Posted: April 10, 2015
Last Update Posted: November 6, 2017