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Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function

This study has been terminated.
(Low enrollment because of the specifics of the inclusion criteria)
Sponsor:
Information provided by (Responsible Party):
Patricia J M Best, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586261
First received: December 21, 2007
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: November 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Interventions: Drug: Pioglitazone
Drug: Placebo
Drug: Nitroglycerin

  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
Patients were recruited from the Mayo Clinic, Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pioglitazone Pioglitazone 30 mg daily for 6 months
Placebo Placebo 30 mg daily for 6 months

Participant Flow:   Overall Study
    Pioglitazone   Placebo
STARTED   17   19 
COMPLETED   17   19 
NOT COMPLETED   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
Pioglitazone Arm

study the specific dose of pioglitazone 30 mg daily for 6 months

pioglitazone : pioglitazone 30 mg daily for 6 months

Placebo Arm

study the specific dose of placebo 30 mg daily for 6 months

placebo : placebo 30 mg daily for 6 months

Total Total of all reporting groups

Baseline Measures
   Pioglitazone Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   19   36 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   4   7 
>=65 years   14   15   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.2  (7.4)   72.1  (8.3)   73.1  (7.9) 
Gender 
[Units: Participants]
     
Female   7   9   16 
Male   10   10   20 
Region of Enrollment 
[Units: Participants]
     
United States   17   19   36 


  Outcome Measures

1.  Primary:   Change in Brachial Arterial Reactivity   [ Time Frame: After 6 months of treatment ]


  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
The study was stopped early due to low enrollment because of the specifics of the inclusion criteria.


  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. Patricia Best
Organization: Mayo Clinic
phone: 507-284-4441
e-mail: best.patricia@mayo.edu



Responsible Party: Patricia J M Best, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586261     History of Changes
Other Study ID Numbers: 06-002245
Study First Received: December 21, 2007
Results First Received: November 13, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board