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Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD

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ClinicalTrials.gov Identifier: NCT03726463
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sung Shin, Asan Medical Center

Tracking Information
First Submitted Date October 28, 2018
First Posted Date October 31, 2018
Last Update Posted Date March 11, 2019
Actual Study Start Date December 20, 2018
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2018)
Intracranial aneurysm [ Time Frame: through study completion, average of 2 years ]
Occurrence of intracranial aneurysm
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03726463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD
Official Title Evaluation of Intima and Media Layer of Iliac and Renal Artery to Verify a Mechanism of Intracranial Aneurysm Development in Autosomal Dominant Polycystic Kidney Disease Patients
Brief Summary

ADPKD is the most common form of hereditary kidney disease and is known to occur in 1 of 400 to 1000 population in the U.S. ADPKD consists of 2.8% of patients receiving kidney transplantation in our center. It is known that ADPKD is associated with vascular anomalies, including abdominal aneurysms, valvular anomalies and especially intracranial aneurysms. Intracranial aneurysms occur in 9~12% of the ADPKD population which is higher than 2~3% in the general population and is known to be associated with PKD1 or PKD2 heritage.

Until now, most of the studies regarding intracranial aneurysms in ADPKD are conducted in animal models, and there are only few cellular studies conducted from human samples. While performing kidney transplantation to ESRD ADPKD patients, arterial tissues from nephrectomy specimens can be obtained. The objective of this study is to investigate the mechanism of intracranial aneurysm in ADPKD patients by analyzing iliac and renal artery characteristics.

Detailed Description

ADPKD is associated with PKD1 gene on chromosome 16 and PKD2 gene on chromosome 4 and these gene respectively code polycystin 1 and polycystin 2. Currently the hypotheses for increased intracranial aneurysm rate in ADPKD patients is that mutation of polycystin is not only confined to nephron tissues but also in endothelial cells and vascular smooth muscle cells and results in mutation of vascular phenotype. Also recent studies show polycystin complex causes cystic changes through mutation in primary cilia in renal epithelium. Wild type endothelial cells respond to fluid shear stress by regulating levels of intracellular calcium and nitric oxide, however, PKD1 or PKD2 mutation in fetal aortic endothelial cells revealed loss of these responses.

During kidney transplantation, bilateral nephrectomies are routinely performed to ADPKD patients. In this study, blood, urine, iliac artery and renal artery tissues will be collected from ADPKD patients receiving kidney transplantation to analyze the arterial characteristic and gene mutation of ADPKD patients. The aim of this study is to evaluate mechanisms associated with intracranial aneurysm occurence in ADPKD patients by analyzing the genetic mutation and vascular deformities of these patients.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
renal artery, iliac artery, serum, urine
Sampling Method Non-Probability Sample
Study Population ADPKD patients from ages 18 to 80 receiving kidney transplantation at Asan Medical Center, which consists of approximately 2.8% of kidney transplantation patients
Condition
  • Kidney Transplant; Complications
  • Polycystic Kidney Diseases
  • Aneurysm, Brain
Intervention Procedure: Kidney transplantation
Bilateral nephrectomy of polycystic kidneys are routinely performed during kidney transplantation in ADPKD patients
Study Groups/Cohorts polycystic kidney disease
patients with polycystic kidney disease who receive kidney transplantation at Asan Medical Center
Intervention: Procedure: Kidney transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 30, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ADPKD patients from ages 18 to 80 receiving kidney transplantation at Asan Medical Center

Exclusion Criteria:

  • those who refuse or are unable to provide consent form
  • pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sung Shin, MD, PhD 82-2-3010-3964 ext 3964 sshin@amc.seoul.kr
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03726463
Other Study ID Numbers 2018-1210
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sung Shin, Asan Medical Center
Study Sponsor Asan Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Asan Medical Center
Verification Date March 2019