Trial Outcomes & Findings for Effect of Adipokines in Hemodialysis Patients (NCT NCT01301027)
NCT ID: NCT01301027
Last Updated: 2016-10-03
Results Overview
The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2016-10-03
Participant Flow
Participant milestones
| Measure |
Pioglitazone
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
COMPLETED
|
40
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Pioglitazone
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Fracture
|
1
|
3
|
|
Overall Study
Transplant
|
0
|
2
|
|
Overall Study
Volume Overload
|
3
|
0
|
Baseline Characteristics
Effect of Adipokines in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=48 Participants
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=47 Participants
Placebo: 1 pill a day for 26 weeks
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.17 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
57.45 years
STANDARD_DEVIATION 14.12 • n=7 Participants
|
58.32 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Body Mass Index
|
32.3 kilograms per meter squared
STANDARD_DEVIATION 6.6 • n=5 Participants
|
32.9 kilograms per meter squared
STANDARD_DEVIATION 7.5 • n=7 Participants
|
32.6 kilograms per meter squared
STANDARD_DEVIATION 7.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: 1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.
The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
Outcome measures
| Measure |
Pioglitazone
n=41 Participants
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=39 Participants
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months
|
38.3 percent difference in geometric mean
Interval 4.9 to 82.2
|
-3.4 percent difference in geometric mean
Interval -27.0 to 27.8
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: 1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.
The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm
Outcome measures
| Measure |
Pioglitazone
n=41 Participants
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=39 Participants
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months
|
-29.0 percent difference in geometric mean
Interval -44.7 to -8.8
|
-1.8 percent difference in geometric mean
Interval -23.8 to 26.5
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.
The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm
Outcome measures
| Measure |
Pioglitazone
n=41 Participants
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=39 Participants
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months
|
44.9 percent difference in geometric mean
Interval 32.9 to 58.1
|
39.1 percent difference in geometric mean
Interval 27.3 to 51.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.
The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm
Outcome measures
| Measure |
Pioglitazone
n=41 Participants
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=39 Participants
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months
|
-12.3 percent difference in geometric mean
Interval -29.7 to 9.6
|
-12.5 percent difference in geometric mean
Interval -30.1 to 9.5
|
Adverse Events
Pioglitazone
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone
n=48 participants at risk
15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=47 participants at risk
1 placebo pill a day matching the pioglitazone treatment for 26 weeks
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac General - Volume Overload
|
0.00%
0/48 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
4.3%
2/47 • Number of events 2 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
General disorders
Death
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
4.3%
2/47 • Number of events 2 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Nervous system disorders
Encephalopathy
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
General disorders
Flu-like Syndrome
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
4.3%
2/47 • Number of events 2 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Colon Cancer
|
0.00%
0/48 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Hemorrhage - Lower GI NOS
|
0.00%
0/48 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Vascular disorders
Hypertension
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Infections and infestations
Infection - Blood (Bacteremia)
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
3/48 • Number of events 3 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Chext/Thorax Pain NOS
|
4.2%
2/48 • Number of events 2 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Hepatobiliary disorders
Pancreatitis
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/48 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Vascular disorders
Fistula failure
|
0.00%
0/48 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
Other adverse events
| Measure |
Pioglitazone
n=48 participants at risk
15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
|
Placebo
n=47 participants at risk
1 placebo pill a day matching the pioglitazone treatment for 26 weeks
Placebo: 1 pill a day for 26 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac General - Volume Overload
|
8.3%
4/48 • Number of events 4 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
6.4%
3/47 • Number of events 3 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
4/48 • Number of events 5 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Nervous system disorders
Dizziness
|
6.2%
3/48 • Number of events 5 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
4.3%
2/47 • Number of events 2 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
3/48 • Number of events 3 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
4.3%
2/47 • Number of events 2 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
3/48 • Number of events 3 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
3/48 • Number of events 3 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Nausea
|
16.7%
8/48 • Number of events 9 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
2.1%
1/47 • Number of events 1 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
8/48 • Number of events 9 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
0.00%
0/47 • 26 Weeks
Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place