ADPKD Alterations in Hepatic Transporter Function

NCT03717883 | Completed

• 2 other identifiers: 16-29845R35GM122576-02
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADPKD; Autosomal Dominant Polycystic Kidney Disease; Renal Disease

Keywords

hepatic transporters

Outcome Measures

Primary Outcomes (1)

• Difference in serum coproporphyrin I and III concentrations

  nmol

  2 hours

Secondary Outcomes (2)

• Difference in serum and urine bile acid profiles

  2 hours

• Difference in renal clearance of coproporphyrin I and III

  2 hours

Study Arms (2)

Healthy subjects

Subjects with ADPKD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy vs. ADPKD vs. non-ADPKD renal disease subjects

You may qualify if:

• Provide signed and dated informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged 18 to 65
• Negative quantitative human chorionic gonadotropin (hCG) blood test (for women of child-bearing age only)
• For healthy subjects:
• Normal liver functions tests (LFTs) as defined by the University of North Carolina (UNC) hospital laboratory reference range \[aspartate aminotransferase (AST)14-38 U/L, alanine aminotransferase (ALT) 15-48 U/L, alkaline phosphatase 38-126 U/L\]
• Normal clinical laboratory results including kidney function (serum creatinine) and lipid panel as reviewed by the study physician
• For subjects with ADPKD:
• Man or woman between the ages of 18 and 65 with documented ADPKD
• For subjects with non-ADPKD renal disease:
• Man or woman between the ages of 18 and 65 with documented non-ADPKD renal disease as determined by the study physician

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27713, United States

Location

Related Publications (19)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples used for potential studies will not be labeled with personal identifiers and will be stored for up to 10 years.

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Kidney Diseases

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Vimal Derebail, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Kim Brouwer, PharmD, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: September 17, 2018
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (1)