Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02697617
• Date of registration: 30/10/2015
• Prospective Registration: Yes
• Primary sponsor: Indiana University
• Public title: Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease PIOPKD
• Scientific title: Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney
• Date of first enrolment: January 26, 2016
• Target sample size: 18
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02697617
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Sharon Moe, 317-944-7580
• Affiliation: Indiana University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female ADPKD patients aged 18-55

- eGFR at or above = 50 ml/min/1.73 m2 by any GFR formula

- 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 as determined by the examining physician

- 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Polycystic Kidney Disease

Intervention(s)

Drug: Placebo

Drug: Pioglitazone

Primary Outcome(s)

To provide information on the safety of pioglitazone therapy in human ADPKD patients over a one year period assessed by edema, tolerance of drug, hematuria, and blood sugar levels. [Time Frame: Quarterly (every 4 months) until the end of the study (predicted study end date is 12/31/2019)]

Secondary Outcome(s)

To provide information on the efficacy of pioglitazone therapy in human ADPKD patients over a one year period using MRI monitoring of total kidney volume. [Time Frame: Baseline, end of year 1, and end of year 2]

To provide information on bone marrow fat content [Time Frame: Baseline, end of year 1, and end of year 2]

Secondary ID(s)

FD-R-004826-01-A2

IndianaU 1308084213

Source(s) of Monetary Support

Please refer to primary and secondary sponsors