Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00324675
First received: May 9, 2006
Last updated: October 27, 2011
Last verified: October 2011
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Overt Diabetic Nephropathy
Interventions: Drug: Rosiglitazone
Drug: 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
recruitment at medical clinic and outpatient department

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 enrolled patients were excluded: one withdrew infromed consent, one developed anaphylactic reaction to sinistrin (used for renal function test)

Reporting Groups
  Description
Rosiglitazone No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Rosiglitazone     Placebo  
STARTED     14     14  
COMPLETED     13     14  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Rosiglitazone No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Rosiglitazone     Placebo     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     5     11  
>=65 years     8     9     17  
Age  
[units: years]
Mean ± Standard Deviation
  65.4  ± 9.6     66.5  ± 8.5     66.1  ± 9.1  
Gender  
[units: participants]
     
Female     2     2     4  
Male     12     12     24  
Region of Enrollment  
[units: participants]
     
Germany     14     14     28  



  Outcome Measures

1.  Primary:   Proteinuria   [ Time Frame: at baseline and after 6 and 12 mo of treatment ]

2.  Secondary:   Renal Hemodynamic   [ Time Frame: at baseline and after 6 and 12 mo of tretament ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Renal Function   [ Time Frame: at abseline and after 6 and 12 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Adverse Event   [ Time Frame: every month or at occurence ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   HbA1c   [ Time Frame: at baseline and after 6 and 12 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Frank Pistrosch
Organization: University Hospital "Carl Gustav Carus", Dresden
phone: 0049 351 4400580
e-mail: frank.pistrosch@uniklinikum-dresden.de


No publications provided by Technische Universität Dresden

Publications automatically indexed to this study:

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00324675     History of Changes
Other Study ID Numbers: DN 2
Study First Received: May 9, 2006
Results First Received: September 15, 2011
Last Updated: October 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices