Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Adipokines in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01301027
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition End Stage Renal Disease
Interventions Drug: Pioglitazone
Drug: Placebo
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks Placebo: 1 pill a day for 26 weeks
Period Title: Overall Study
Started 48 47
Completed 40 37
Not Completed 8 10
Reason Not Completed
Physician Decision             2             0
Withdrawal by Subject             2             3
Adverse Event             0             2
Fracture             1             3
Transplant             0             2
Volume Overload             3             0
Arm/Group Title Pioglitazone Placebo Total
Hide Arm/Group Description Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks Placebo: 1 pill a day for 26 weeks Total of all reporting groups
Overall Number of Baseline Participants 48 47 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 47 participants 95 participants
59.17  (12.01) 57.45  (14.12) 58.32  (13.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
Female
13
  27.1%
13
  27.7%
26
  27.4%
Male
35
  72.9%
34
  72.3%
69
  72.6%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter squared
Number Analyzed 48 participants 47 participants 95 participants
32.3  (6.6) 32.9  (7.5) 32.6  (7.0)
1.Primary Outcome
Title Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months
Hide Description The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
Placebo: 1 pill a day for 26 weeks
Overall Number of Participants Analyzed 41 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
38.3
(4.9 to 82.2)
-3.4
(-27.0 to 27.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months
Hide Description The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
Placebo: 1 pill a day for 26 weeks
Overall Number of Participants Analyzed 41 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
-29.0
(-44.7 to -8.8)
-1.8
(-23.8 to 26.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months
Hide Description The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
Placebo: 1 pill a day for 26 weeks
Overall Number of Participants Analyzed 41 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
44.9
(32.9 to 58.1)
39.1
(27.3 to 51.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months
Hide Description The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:
Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
Placebo: 1 pill a day for 26 weeks
Overall Number of Participants Analyzed 41 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
-12.3
(-29.7 to 9.6)
-12.5
(-30.1 to 9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 26 Weeks
Adverse Event Reporting Description Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through Week 26
 
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description

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

1 placebo pill a day matching the pioglitazone treatment for 26 weeks

Placebo: 1 pill a day for 26 weeks

All-Cause Mortality
Pioglitazone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pioglitazone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/48 (22.92%)      10/47 (21.28%)    
Cardiac disorders     
Cardiac General - Volume Overload  1  0/48 (0.00%)  0 2/47 (4.26%)  2
Gastrointestinal disorders     
Colon Cancer  1  0/48 (0.00%)  0 1/47 (2.13%)  1
Hemorrhage - Lower GI NOS  1  0/48 (0.00%)  0 1/47 (2.13%)  1
Small Bowel Obstruction  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Abdominal Pain NOS  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Vomiting  1  1/48 (2.08%)  1 0/47 (0.00%)  0
General disorders     
Death  1  1/48 (2.08%)  1 2/47 (4.26%)  2
Flu-like Syndrome  1  1/48 (2.08%)  1 1/47 (2.13%)  1
Hepatobiliary disorders     
Pancreatitis  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Infections and infestations     
Infection - Blood (Bacteremia)  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fracture  1  1/48 (2.08%)  1 2/47 (4.26%)  2
Nervous system disorders     
Encephalopathy  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Renal and urinary disorders     
Renal Failure  1  0/48 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Pneumonia  1  3/48 (6.25%)  3 0/47 (0.00%)  0
Chext/Thorax Pain NOS  1  2/48 (4.17%)  2 1/47 (2.13%)  1
Respiratory Failure  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Vascular disorders     
Hypertension  1  1/48 (2.08%)  1 0/47 (0.00%)  0
Fistula failure  1  0/48 (0.00%)  0 1/47 (2.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pioglitazone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/48 (33.33%)      6/47 (12.77%)    
Cardiac disorders     
Cardiac General - Volume Overload  1  4/48 (8.33%)  4 3/47 (6.38%)  3
Gastrointestinal disorders     
Diarrhea  1  4/48 (8.33%)  5 1/47 (2.13%)  1
Nausea  1  8/48 (16.67%)  9 1/47 (2.13%)  1
Vomiting  1  8/48 (16.67%)  9 0/47 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalemia  1  3/48 (6.25%)  3 0/47 (0.00%)  0
Hypoglycemia  1  3/48 (6.25%)  3 0/47 (0.00%)  0
Nervous system disorders     
Dizziness  1  3/48 (6.25%)  5 2/47 (4.26%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  3/48 (6.25%)  3 2/47 (4.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Layout table for Results Point of Contact information
Name/Title: Srinivansan Beddhu, M.D.
Organization: University of Utah
Phone: 801-585-3810
EMail: srinivansan.beddhu@hsc.utah.edu
Layout table for additonal information
Responsible Party: Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier: NCT01301027    
Other Study ID Numbers: IRB_00028427
R01DK078112 ( U.S. NIH Grant/Contract )
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: August 9, 2016
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016