- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02739750
Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease
January 24, 2022 updated by: Ranjani Moorthi, Indiana University
Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease (CKD) Sub-study to Protocol Number 1308084213
Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates.
A component of bone is marrow.
Bone marrow fat is increased in patients with CKD compared to those in the normal population of the same age.
It is not clear if there will be changes in the marrow fact content in those with CKD on Pioglitazone.
In people with normal kidney function, thiazolidinedione group of drugs have had variable effects on bone marrow fat content, as measured by MRS.
This is important as changes in marrow fat are likely related to changes in the bone in patients with chronic kidney disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
If patients consent to participate in the ancillary study of marrow fat changes with pioglitazone, those that are randomized to placebo or 15 mg pioglitazone for 12 months (per the criteria in the main study) will also undergo magnetic resonance spectroscopy (MRS) of the lumbar spine at L1, L2 and L3.
MR spectroscopy of the lumbar spine (if they choose as this is ancillary study) will be performed 3 times over the course of the study.
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
PKD subjects that consent to the FDA study, number 1308084213, will be approached for consenting for this bone marrow fat study.
Subject must be enrolled in NCT#02697617
Description
Inclusion Criteria:
- Included subjects will be those who consent to the study of Pioglitazone in ADPKD (Protocol number 1308084213). Therefore inclusion and exclusion criteria are the same as for that study. Subjects will NOT be offered participation in the bone marrow fat study till after they consent for the FDA approved study. Subjects who withdraw from the FDA approved study will be withdrawn from this protocol.
Inclusion/Exclusion Criteria for NCT#02697617
- Male or female ADPKD patients aged 18-55
- eGFR at or above ≥ 50 ml/min/1.73 m2 by 4 parameter MDRD or CKD-Epiformulas
- normal liver enzymes (ALT/AST)
- fasting blood glucose between 70 and120
- for female patients, a willingness to use double contraception to avoid pregnancy while in study
- able to give informed consent
- In the opinion of the investigator, high likelihood of progressive kidney disease
Exclusion Criteria:
- diabetes, defined as any of the following: fasting blood sugar > 130 times two, HgbA1C > 7, on any blood sugar lowering medication, or past diagnosis of diabetes not occurring during pregnancy
- uncontrolled hypertension, defined as systolic > 150, diastolic > 90 despite an attempt by physician to titrate medications
- history of impaired systolic function (ejection fraction < 50%) by previous ECHO or known ischemic cardiovascular disease
- findings suggestive of a kidney disease other than ADPKD
- systemic illness requiring immunosuppressive or anti-inflammatory agents
- congenital absence of a kidney or history of a total nephrectomy
- history of cyst reduction or partial nephrectomy
- history of renal cyst aspiration within the previous year
- History of bladder cancer, or gross hematuria
- inability to undergo MRI due to implantable devices or foreign objects that preclude MRI
- active renal transplant
- allergy or sensitivity to any of the components of the test materials
- institutionalized
- currently pregnant or plans to become pregnant during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percent change in the bone marrow lipid fraction averaged between L2, L3 and L4 at baseline to 12 months and 12 months to 24 months.
Time Frame: Baseline, 12 months, 24 months
|
Subjects will undergo and MRI at Baseline, 12 months, and 24 months to measure bone marrow.
|
Baseline, 12 months, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ranjani Moorthi, MD, Faculty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ACTUAL)
October 1, 2019
Study Completion (ACTUAL)
October 1, 2019
Study Registration Dates
First Submitted
March 23, 2016
First Submitted That Met QC Criteria
April 11, 2016
First Posted (ESTIMATE)
April 15, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 26, 2022
Last Update Submitted That Met QC Criteria
January 24, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Indiana U 1511993513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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