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.

Study NCT00324675 Information provided by Dresden University of Technology

First Received on May 9, 2006. Last Updated on October 27, 2011 History of Changes

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

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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 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

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Reporting Groups

	Description
Rosiglitazone	No text entered.
Placebo	No text entered.

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 ]

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2. Secondary:

Renal Hemodynamic [ Time Frame: at baseline and after 6 and 12 mo of tretament ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Renal Function [ Time Frame: at abseline and after 6 and 12 mo ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Secondary:

Adverse Event [ Time Frame: every month or at occurence ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

5. Secondary:

HbA1c [ Time Frame: at baseline and after 6 and 12 mo ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

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.

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

Responsible Party:	Dresden University of Technology
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