End Stage Renal DiseaseNCT01301027

Effect of Adipokines in Hemodialysis Patients

A study testing Pioglitazone in people with End Stage Renal Disease, run by University of Utah at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and whether these changes result in reduction of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: Pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 2 sitesUnited States
Study dates: May 2008to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Overweight (Body Mass Index ≥ 25 kilograms per meter squared (kg/m2))
Adult (18 years or older)
Chronic hemodialysis patient
Diabetic (type 2) or insulin resistant

Who cannot join

<18 years old
No insulin resistance
Active liver disease
Class III or IV New York Heart Association heart failure
Macular edema or hard exudates near macula on fundoscopy
Current active malignancy (excluding squamous and basal cell skin cancers)

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Active AIDS
Chronic lung disease requiring supplemental oxygen therapy
Enrolled in interventional trials using drugs or devices
Bone break of long bones, vertebrae, or hips in the past three years

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Colorado
Denver, Colorado, 80262
University of Utah
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Effects of Pioglitazone on Adiponectin and Inflammatory Markers in Overweight or Obese Hemodialysis Patients: A Double-Blinded Randomized Controlled Trial

In addition, this study will also examine the associations of adiposity with adipokines and the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes in uremic milieu.

Read the detailed description

Randomization:

100 overweight or obese patients will be randomly allocated to oral pioglitazone 15 mg/d or placebo for two weeks by blocks of five using a random number generator and monitored for adverse events including hypoglycemia. If they tolerate the 15 mg pioglitazone or matching placebo for two weeks, participants will be assigned to 30 mg of pioglitazone or matching placebo for 24 more weeks. Those who received 15 mg of pioglitazone will receive 30 mg of pioglitazone for the next 24 weeks. Those who received placebo for initial 2 weeks will receive another placebo that matches the 30 mg pioglitazone pill for 24 weeks.

Baseline:

Participants will have fasting blood drawn for adipokines: Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), high sensitivity C-Reactive Protein (hsCRP), high molecular weight Adiponectin (HMW-A), and leptin. All patients will undergo MRI scans on the mid-week non-dialysis day. Twenty each of overweight/obese patients randomized to pioglitazone or placebo will also undergo subcutaneous fat biopsy on the mid-week non-dialysis day.

Study Period:

Participants will return to the dialysis unit at weeks 2, 4, 6, 10, 14, 18, 22, and 26. During these visits, clinical assessments will be conducted including review of blood sugars, jaundice, weight gain, and visual symptoms. Study treatment compliance will be assessed and details of adverse events experienced, particularly hospitalizations and emergency department visits will be collected. Fasting blood draws for primary and secondary outcomes will be collected on visit weeks 10 and 26.

Conditions: End Stage Renal Disease
Being tested: Pioglitazone, Placebo
Keywords: End stage renal disease, Hemodialysis, Pioglitazone, Adipokines
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PioglitazoneDrug
Also called Actos
15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
PlaceboDrug
1 pill a day for 26 weeks

Study groups in NCT01301027
Study group	Role	What they receive
Pioglitazone	Active comparator	15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks Receives: Drug: Pioglitazone
Placebo	Placebo comparator	1 placebo pill a day matching the pioglitazone treatment for 26 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months
The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
Measured: Baseline and 6 months
Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months
The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm
Measured: Baseline and 6 months

Secondary outcomes (2)

Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months
The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm
Measured: Baseline and 6 months
Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months
The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Dec 2015

First posted23 Feb 2011 (estimated)
Study startMay 2008
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301027
Sponsor's protocol ID: IRB_00028427
Other IDs: R01DK078112
Status last verified: Aug 2016
First submitted: 18 Feb 2011
Last updated: 3 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Physical Impairments in Children With Chronic Renal Failure
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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pioglitazone on Adiponectin and Inflammatory Markers in Overweight or Obese Hemodialysis Patients: A Double-Blinded Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01301027
Acronym / sponsor ID: IRB_00028427
Conditions: End Stage Renal Disease
Keywords: End stage renal disease, Hemodialysis, Pioglitazone, Adipokines
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
Study start: May 2008
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 23 Feb 2011 (estimated)
Results: Posted 3 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Randomization:

Baseline:

Study Period:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pioglitazone	Active comparator	Drug: Pioglitazone15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks
Placebo	Placebo comparator	Drug: Placebo1 placebo pill a day matching the pioglitazone treatment for 26 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Overweight (Body Mass Index ≥ 25 kilograms per meter squared (kg/m2))
Adult (18 years or older)
Chronic hemodialysis patient
Diabetic (type 2) or insulin resistant

Key exclusion criteria (10 listed)

<18 years old
No insulin resistance
Active liver disease
Class III or IV New York Heart Association heart failure
Macular edema or hard exudates near macula on fundoscopy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PioglitazoneAlso: Actos15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks	Drug	Pioglitazone
Placebo1 pill a day for 26 weeks	Drug	Placebo

Primary outcome

Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months
Time frame: Baseline and 6 months
The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months
Time frame: Baseline and 6 months
The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm

2 secondary outcomes

Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 3 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone	48	40
Placebo	47	37

Primary outcome: Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months

Time frame: Baseline and 6 months. Geometric mean (95% Confidence Interval). Unit: percent difference in geometric mean

Measure	Pioglitazone n = 41	Placebo n = 39
Value	38.3 (4.9 to 82.2)	-3.4 (-27.0 to 27.8)

Pioglitazone vs Placebo: p = 0.047, t-test, 2 sided

Population analysed: 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.

Primary outcome: Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months

Time frame: Baseline and 6 months. Geometric mean (95% Confidence Interval). Unit: percent difference in geometric mean

Measure	Pioglitazone n = 41	Placebo n = 39
Value	-29.0 (-44.7 to -8.8)	-1.8 (-23.8 to 26.5)

Pioglitazone vs Placebo: p = 0.059, t-test, 2 sided

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 26 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone	11 of 48 (22.9%)	16 of 48 (33.3%)	Not reported
Placebo	10 of 47 (21.3%)	6 of 47 (12.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Srinivasan Beddhu, M.D. principal investigator

University of Utah

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pioglitazone in people with End Stage Renal Disease, run by University of Utah at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01301027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.