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Trial record 23 of 123 for:    Polycystic Kidney Disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Sharon Moe, Indiana University
ClinicalTrials.gov Identifier:
NCT02697617
First received: October 30, 2015
Last updated: October 13, 2016
Last verified: May 2016
  Purpose

Funding Source - FDA OOPD

Pioglitazone is currently used in clinical practice to treat diabetes and this study will examine the potential use of a low dose of the same drug for the treatment of polycystic kidney disease. The purpose of this study is to determine whether the diabetes drug pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest that effective pioglitazone dosing for polycystic kidney disease may be lower than that used to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst disease in humans.


Condition Intervention Phase
Polycystic Kidney Disease
Drug: Pioglitazone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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) ]
    Assessment of edema, tolerance of drug, hematuria, and blood sugar levels.


Secondary Outcome Measures:
  • 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 ]
    We will assess change in kidney volume by MRI, change in liver volume by MRI.

  • To provide information on bone marrow fat content [ Time Frame: Baseline, end of year 1, and end of year 2 ]
    We will assess change in bone marrow fat by MR spectroscopy as an ancillary study to be done at the same time as MRI


Estimated Enrollment: 28
Study Start Date: October 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm
Subject will be on placebo
Drug: Placebo
Placebo
Active Comparator: Pioglitazone Arm
Subject will be on pioglitazone
Drug: Pioglitazone
Pioglitazone
Other Name: Actos

Detailed Description:
Patients will be randomize to placebo or 15 mg pioglitazone for 12 months, and then be crossed over to the other arm. Patients will undergo MRI of the liver and kidney and MRspectroscopy of the lumbar spine (if they choose as this is ancillary study) three times during the study. Assessments will be every 3 months and include blood work, blood pressure, and body water assessments.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02697617

Contacts
Contact: Sharon Moe, MD 317-278-2868 smoe@iu.edu
Contact: Kristen Ponsler-Sipes 317-944-7580 kmponsle@iu.edu

Locations
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kristen Ponsler-Sipes    317-944-7580    kmponsle@iu.edu   
Contact: Bonnie Blazer-Yost       bblazer@iupui.edu   
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Sharon Moe, 317-944-7580 Indiana University
  More Information

Responsible Party: Sharon Moe, MD, Stuart A. Kleit Professor of Medicine, Director, Division of Nephrology, Indiana University
ClinicalTrials.gov Identifier: NCT02697617     History of Changes
Other Study ID Numbers: IndianaU 1308084213
FD-R-004826-01-A2 ( Other Identifier: FDA Orphan Products Development Ad Hoc Panel Review )
Study First Received: October 30, 2015
Last Updated: October 13, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017