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

NCT03726463 | Unknown

• 1 other identifier: 2018-1210
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Polycystic Kidney Diseases; Aneurysm, Brain

Outcome Measures

Primary Outcomes (1)

• Intracranial aneurysm

  Occurrence of intracranial aneurysm

  through study completion, average of 2 years

Study Arms (1)

polycystic kidney disease

patients with polycystic kidney disease who receive kidney transplantation at Asan Medical Center

Procedure: Kidney transplantation

Interventions

Kidney transplantation PROCEDURE

Bilateral nephrectomy of polycystic kidneys are routinely performed during kidney transplantation in ADPKD patients

polycystic kidney disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• those who refuse or are unable to provide consent form
• pregnancy

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Publications (4)

• Iglesias CG, Torres VE, Offord KP, Holley KE, Beard CM, Kurland LT. Epidemiology of adult polycystic kidney disease, Olmsted County, Minnesota: 1935-1980. Am J Kidney Dis. 1983 May;2(6):630-9. doi: 10.1016/s0272-6386(83)80044-4.

  PMID: 6846334 BACKGROUND

• Collins AJ, Foley RN, Chavers B, Gilbertson D, Herzog C, Johansen K, Kasiske B, Kutner N, Liu J, St Peter W, Guo H, Gustafson S, Heubner B, Lamb K, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Thompson B, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Daniels F, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. 'United States Renal Data System 2011 Annual Data Report: Atlas of chronic kidney disease & end-stage renal disease in the United States. Am J Kidney Dis. 2012 Jan;59(1 Suppl 1):A7, e1-420. doi: 10.1053/j.ajkd.2011.11.015. No abstract available.

  PMID: 22177944 BACKGROUND

• Torres VE, Harris PC, Pirson Y. Autosomal dominant polycystic kidney disease. Lancet. 2007 Apr 14;369(9569):1287-1301. doi: 10.1016/S0140-6736(07)60601-1.

  PMID: 17434405 BACKGROUND

• Ecder T, Schrier RW. Cardiovascular abnormalities in autosomal-dominant polycystic kidney disease. Nat Rev Nephrol. 2009 Apr;5(4):221-8. doi: 10.1038/nrneph.2009.13.

  PMID: 19322187 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

renal artery, iliac artery, serum, urine

MeSH Terms

Conditions

Polycystic Kidney Diseases; Intracranial Aneurysm

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; 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; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Sung Shin, MD, PhD

CONTACT

82-2-3010-3964; sshin@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 31, 2018
• Study Start: December 20, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)