ADPKD Alterations in Hepatic Transporter Function
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|ClinicalTrials.gov Identifier: NCT03717883|
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : March 25, 2020
|Condition or disease|
|ADPKD Autosomal Dominant Polycystic Kidney Disease Renal Disease|
ADPKD is a relatively common genetic disease affecting about 1 out of every 1000 people worldwide. Progression of ADPKD is characterized by the proliferation of fluid-filled kidney cysts. Development of these cysts is progressive and can lead to end-stage renal disease and ultimately, renal failure in many patients. The most common extra-renal complication of ADPKD is the formation of liver cysts, which can vary from minor to extensive. Hepatic cysts can develop from medium-sized bile ducts and complications (i.e., cyst rupture, infection, obstruction of bile ducts, and compromised portal venous flow) can arise from increasing cystic burden. Previous studies have shown that elevated levels of endogenous molecules such as bile acids in ADPKD may indicate altered transporter function. Other endogenous molecules such as coproporphyrin (CP) I and III may be used as probes to assess hepatic transporter function.
The objective of this study is to investigate and quantify ADPKD-associated alterations in endogenous molecule profiles (e.g., bile acids, CP) relative to subjects with non-ADPKD renal disease and healthy individuals, and to investigate specific hepatic transporter polymorphisms that may be related to the alterations. This is important because subjects with ADPKD may be predisposed to adverse reactions associated with some medications that require hepatic transporters for excretion.
Potential study participants will be pre-screened over the phone and then scheduled for a 2-hour study visit. All urine samples within the 2-hour interval will be collected from all participants along with clinical, physical and questionnaire data. Fasting blood samples will be collected at time 0 and 120 min.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Endogenous Molecule Profiling in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)|
|Actual Study Start Date :||September 17, 2018|
|Actual Primary Completion Date :||January 29, 2020|
|Actual Study Completion Date :||January 29, 2020|
|Subjects with ADPKD|
- Difference in serum coproporphyrin I and III concentrations [ Time Frame: 2 hours ]nmol
- Difference in serum and urine bile acid profiles [ Time Frame: 2 hours ]nmol
- Difference in renal clearance of coproporphyrin I and III [ Time Frame: 2 hours ]mL/min
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717883
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27713|
|Principal Investigator:||Vimal Derebail, MD, MPH||University of North Carolina, Chapel Hill|
|Study Director:||Kim Brouwer, PharmD, PhD||University of North Carolina, Chapel Hill|