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
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.
|Condition or disease||Intervention/treatment|
|Kidney Transplant; Complications Polycystic Kidney Diseases Aneurysm, Brain||Procedure: Kidney transplantation|
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|
|Estimated Enrollment :||100 participants|
|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|
|Actual Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
polycystic kidney disease
patients with polycystic kidney disease who receive kidney transplantation at Asan Medical Center
Procedure: Kidney transplantation
Bilateral nephrectomy of polycystic kidneys are routinely performed during kidney transplantation in ADPKD patients
- Intracranial aneurysm [ Time Frame: through study completion, average of 2 years ]Occurrence of intracranial aneurysm
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): NCT03726463
|Contact: Sung Shin, MD, PhD||82-2-3010-3964 ext email@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 05505|
|Contact: SUNG SHIN, Dr.|