Polycystic Kidney DiseasesNCT02739750
Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease
An observational study of Polycystic Kidney Diseases, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Polycystic Kidney Diseases
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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 Subjects who withdraw from the FDA approved study will be withdrawn from this protocol.
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Kidney Diseases
- Being tested
- No intervention
- Medical subject headings
- Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention for this study. It is a MRS.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Subjects will undergo and MRI at Baseline, 12 months, and 24 months to measure bone marrow.
Measured: Baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranjani Moorthi, Indiana University
- Investigators
- Ranjani Moorthi, MD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739750
- Sponsor's protocol ID
- Indiana U 1511993513
- Status last verified
- Jan 2022
- First submitted
- 23 Mar 2016
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease (CKD) Sub-study to Protocol Number 1308084213
- ClinicalTrials.gov ID
- NCT02739750
- Acronym / sponsor ID
- Indiana U 1511993513
- Conditions
- Polycystic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (8 listed)
- 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.
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| No interventionThere is no intervention for this study. It is a MRS. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Ranjani Moorthi, MD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Kidney Diseases, run by Indiana University at 1 site 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 8 inclusion and 14 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2022.