Trial Outcomes & Findings for Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy (NCT NCT00324675)

NCT ID: NCT00324675

Last Updated: 2011-11-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: at baseline and after 6 and 12 mo of treatment
• Results posted on: 2011-11-02

Participant Flow

recruitment at medical clinic and outpatient department

2 enrolled patients were excluded: one withdrew infromed consent, one developed anaphylactic reaction to sinistrin (used for renal function test)

Participant milestones

Measure	Rosiglitazone	Placebo
Overall Study STARTED	14	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Rosiglitazone	Placebo
Overall Study Adverse Event	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rosiglitazone n=14 Participants	Placebo n=14 Participants	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age Continuous	65.4 years STANDARD_DEVIATION 9.6 • n=5 Participants	66.5 years STANDARD_DEVIATION 8.5 • n=7 Participants	66.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: at baseline and after 6 and 12 mo of treatment

Population: per protocol

Outcome measures

Measure	Rosiglitazone n=13 Participants	Placebo n=14 Participants
Proteinuria baseline	2.4 g/24hr Standard Error 1.1	1.6 g/24hr Standard Error 0.6
Proteinuria 6 mo	1.2 g/24hr Standard Error 0.6	1.6 g/24hr Standard Error 0.8
Proteinuria 12 mo	1.5 g/24hr Standard Error 0.7	1.7 g/24hr Standard Error 0.8

SECONDARY outcome

Timeframe: at baseline and after 6 and 12 mo of tretament

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at abseline and after 6 and 12 mo

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every month or at occurence

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline and after 6 and 12 mo

Outcome measures

Outcome data not reported

Adverse Events

Rosiglitazone

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rosiglitazone n=14 participants at risk	Placebo n=14 participants at risk
Respiratory, thoracic and mediastinal disorders sleep apnoe	7.1% 1/14 • Number of events 1	0.00% 0/14
Renal and urinary disorders acute kidney injury	0.00% 0/14	7.1% 1/14 • Number of events 1
Cardiac disorders atrial fibrillation with congestive heart failure	0.00% 0/14	7.1% 1/14 • Number of events 1

Other adverse events

Measure	Rosiglitazone n=14 participants at risk	Placebo n=14 participants at risk
Skin and subcutaneous tissue disorders peripheral edema	57.1% 8/14 • Number of events 8	21.4% 3/14 • Number of events 3
Blood and lymphatic system disorders anemia new or worsening	28.6% 4/14 • Number of events 4	28.6% 4/14 • Number of events 4
Endocrine disorders hypoglycemia	14.3% 2/14 • Number of events 2	0.00% 0/14
Musculoskeletal and connective tissue disorders painful calf or foot	21.4% 3/14 • Number of events 3	7.1% 1/14 • Number of events 1
Vascular disorders hypotension	14.3% 2/14 • Number of events 2	0.00% 0/14
Infections and infestations common cold	7.1% 1/14 • Number of events 1	7.1% 1/14 • Number of events 1

Additional Information

Dr. Frank Pistrosch

University Hospital "Carl Gustav Carus", Dresden

Phone: 0049 351 4400580

Email: frank.pistrosch@uniklinikum-dresden.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place