ADPKD Alterations in Hepatic Transporter Function

Completed

Conditions studied: ADPKD, Autosomal Dominant Polycystic Kidney Disease, Renal Disease

In brief

This is a single center, comparative cohort study to investigate alterations in hepatic transporter function in subjects with autosomal dominant polycystic kidney disease (ADPKD) compared to healthy subjects and subjects with non-ADPKD renal disease. Eligible subjects will be 18-65 years of age and of any race/ethnicity and gender.

Key facts

Study ID

NCT03717883

Run by

University of North Carolina, Chapel Hill

People needed

24

Starts

2018-09-17

Expected to finish

2020-01-29

Last updated by the study team

2020-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• All Participants:
• Donation of blood within the last 30 days
• Diagnosis of human immunodeficiency virus (HIV) and/or untreated hepatitis C virus (HCV)
• History of significant alcohol abuse and/or illicit drug use
• More than 1 glass of wine or 2 beers (or equivalent in % alcohol) per day during the 48 hours prior to study and/or screening visit
• Inability to fast for 8 hours prior to study and screening sample collection
• Women who are pregnant, trying to become pregnant, or breastfeeding
• Current or recent (within 30 days) use of bile acid sequestrants, bile acid derivatives (i.e. ursodiol) or fibric acid derivatives
• History of diabetes or taking blood glucose lowering treatments
• Radiologic imaging consistent with cirrhosis and portal hypertension
• Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dL, total bilirubin > 1.5 mg/dL, or prothrombin time (PT)/international normalized ratio (INR) > 1.3 times normal at screening, or history or presence of ascites, encephalopathy, or bleeding from esophageal varices
• Estimated glomerular filtration rate (GFR)< 15 mL/min per 1.73 m2, or on dialysis, at screening
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications (including inhaled) within 14 days of study visit. Corticosteroids with minimal systemic absorption (for example topical) and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease provided the dose has been stable for ≥4 weeks and is not expected to change during the course of the study.
• Primary, secondary or extra-hepatic malignancy
• BMI > 35 kg/m2 at screening
• Inability or unwillingness to give informed consent or abide by the study protocol
• History or other evidence of illness, any gastrointestinal surgery (e.g., gall bladder removal), or any other conditions or drug therapies that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, gall bladder disease, active gastrointestinal conditions or taking drugs known to interfere with bile acid synthesis or metabolism or the metabolism/transport of other drugs)
• Healthy Subjects:
• Taking concomitant medications, both prescription and non-prescription (including herbal products and over-the-counter medications), other than oral contraceptives and multivitamins (women stabilized on hormonal methods of birth control will be allowed to participate)
• History or other evidence of liver, gall bladder, or intestinal disease in the opinion of the study investigators
• BMI > 35 kg/m2 at screening.
• Subjects with non-ADPKD renal disease:
• ADPKD
• Proteinuria of ≥3 grams per day of protein into the urine; or on a single spot urine collection, the presence of ≥2 grams of protein per gram of urine creatinine (i.e., excluding patients with nephrotic-range proteinuria)
• Diabetic nephropathy patients

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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