Trial Outcomes & Findings for Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients (NCT NCT03471117)
NCT ID: NCT03471117
Last Updated: 2026-07-27
Results Overview
Multiunit postganglionic MSNA will be recorded using standard microneurographic techniques. Briefly, a unipolar tungsten microelectrode will be inserted into the peroneal nerve near the fibular head of the leg. Neural signals will be amplified, filtered (bandwidth, 700-2,000 Hz), rectified, and integrated (time constant, 0.1 s) to obtain mean voltage neurograms.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
1 month
Results posted on
2026-07-27
Participant Flow
Recruitment performed at UT Southwestern Medical Center and Parkland Hospital.
Participant milestones
| Measure |
Pioglitazone First, Then Placebo
The subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
Next, participant will be given Placebo pills for 1 month. The placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills.
|
Placebo First, Then Pioglitazone
Participant will be given Placebo pills for 1 month. The placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills.
Next, the subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
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|---|---|---|
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Overall Study
STARTED
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2
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2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=4 Participants
The study design uses a crossover design in which all participants received both pioglitazone and placebo during separate periods, and that baseline assessments were conducted prior to each intervention period but for reporting purposes, baseline values are being presented as one value per participant to avoid double counting.
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|---|---|
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Age, Continuous
|
66 years
STANDARD_DEVIATION 3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Muscle Sympathetic Nerve Activity
|
41 burst per min
STANDARD_DEVIATION 10 • n=9 Participants
|
|
Mean Arterial Blood Pressure
|
110 mmHg
STANDARD_DEVIATION 24 • n=9 Participants
|
|
Flow Mediated Dilation
|
3.7 percent change
STANDARD_DEVIATION 1.5 • n=9 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: One participant elected not to perform the MSNA measure after consenting.
Multiunit postganglionic MSNA will be recorded using standard microneurographic techniques. Briefly, a unipolar tungsten microelectrode will be inserted into the peroneal nerve near the fibular head of the leg. Neural signals will be amplified, filtered (bandwidth, 700-2,000 Hz), rectified, and integrated (time constant, 0.1 s) to obtain mean voltage neurograms.
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
The subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
|
Placebo
n=4 Participants
Participant will be given Placebo pills for 1 month. The placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills.
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|---|---|---|
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Muscle Sympathetic Nerve Activity (MSNA)
|
43 MSNA burst frequency (bursts/min)
Standard Deviation 8
|
41 MSNA burst frequency (bursts/min)
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Measure of mean arterial blood pressure in mmHg
Measure of mean arterial blood pressure in mmHg
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
The subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
|
Placebo
n=4 Participants
Participant will be given Placebo pills for 1 month. The placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills.
|
|---|---|---|
|
Mean Arterial Blood Pressure
|
112 mmHg
Standard Deviation 26
|
110 mmHg
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 1 monthPopulation: percent dilation following 5 min cuff occlusion and subsequent release
measure of vascular endothelial function assessed as flow mediated dilation
Outcome measures
| Measure |
Pioglitazone
n=4 Participants
The subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
|
Placebo
n=4 Participants
Participant will be given Placebo pills for 1 month. The placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills.
|
|---|---|---|
|
Flow Mediated Dilation
|
3.5 % dilation
Standard Deviation 1.9
|
3.7 % dilation
Standard Deviation 1.5
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place