Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease

Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease (CKD) Sub-study to Protocol Number 1308084213

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02739750

Enrollment

Registered

2016-04-15

Start date

2016-01-31

Completion date

2019-10-31

Last updated

2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Kidney Diseases

Brief 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. 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.

Interventions

OTHERNo intervention

There is no intervention for this study. It is a MRS.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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 Subjects who withdraw from the FDA approved study will be withdrawn from this protocol.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/

Design outcomes

Primary

Measure	Time frame	Description
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.	Baseline, 12 months, 24 months	Subjects will undergo and MRI at Baseline, 12 months, and 24 months to measure bone marrow.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026