KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Lupus Nephritis Clinical Trial

— KORNERSTONE  

Official title:

Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929887
• Other study ID #: KORNERSTONE
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: Yong Chul Kim, MD,PhD.
• Phone: +82-10-8874-7429
• Email: imyongkim[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Glomerulonephritis (GN) generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain.

Recently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology.

In response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, multi-center N network has been established for prospective cohort with kidney biopsy samples (KORNERSTONE).

Through this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.

Description:

Glomerulonephritis (GN) such as Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), Membranous nephropathy (MN), and Immunoglobulin A nephropathy (IgAN) has quite a common clinical presentation often results in renal insufficiency which generates an enormous individual and social economic burden.

However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain.

Recently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology.

In response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, a number of universities joined together to establish Korean Kidney Biopsy Network (KORNERSTONE).

Through this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.

============

1. Blood tests: CBC, Chemistry (Ca, P, Glucose, Total protein, Albumin, Uric acid), Electrolyte, Renal function (BUN, Creatinine, eGFR), Liver function (AST, ALT)

2. Immunologic blood tests: Complement 3, Complement 4, ASO, RF, Cryoglobulin, dsDNA, ANA

3. Urine tests: Urinalysis, Urine protein, Urine albumin, Urine creatinine

4. Radiologic tests: Kidney USG, Abdominal-pelvis computed tomography

5. Pathologic results

6. Treatment informations: treatment status, drug type, treatment duration

7. Quality of life questionnaire: Kidney Disease and Quality of Life Short Form survey (adults), PedsQL 4.0 Generic Core Scales (pediatrics)

8. Dietary questionnaire

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

1. Inclusion criteria

• Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers

• Children (age<18 years) also included

2. Exclusion criteria - Patients who previously received a kidney transplant

Related Conditions & MeSH terms

• Crescentic Glomerulonephritis
• Focal Segmental Glomerulosclerosis
• Glomerular Disease
• Glomerulonephritis
• Glomerulonephritis, IGA
• Glomerulonephritis, Membranous
• Glomerulosclerosis, Focal Segmental
• IgA Nephropathy
• Kidney Diseases
• Lupus Nephritis
• Membranous Nephropathy
• Minimal Change Disease
• Nephritis
• Nephrosis, Lipoid

Intervention

Other:
• Kidney Biopsy
Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.

Locations

Country	Name	City	State
Korea, Republic of	KangWon National University Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chung-Ang University Hosptial	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (8)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chung-Ang University Hosptial, Chung-Ang University College of Medicine, KangWon National University Hospital, Keimyung University Dongsan Medical Center, Ministry of Health & Welfare, Korea, Seoul National University Bundang Hospital, Severance Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Documentation of death from any cause	60 months
Primary	Deterioration of renal outcomes	Doubling of serum creatinine compared to baseline serum creatinine; 30% decline in follow-up estimated GFR (using the MDRD equation and/or the CKD-EPI equation) compared to baseline measurement; End stage renal disease defined as estimated GFR =10cc/min, initiation of maintenance dialysis or kidney transplantation.	60 months
Primary	Improvement of clinical outcomes	Remission of glomerulonephritis and proteinuria <0.3g/day (pateint who have proteinuria<0.3g/day at baseline have no improvement in clinical outcomes)	60 months
Secondary	Malignancies	Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment	60 months
Secondary	Infections, Serious and Systemic	Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.	60 months
Secondary	Acute Kidney Injury	Documented diagnosis of acute kidney injury as defined by the RIFLE criteria and/or renal failure requiring renal replacement therapy <3 months.	60 months
Secondary	Hospitalization	Documented hospital admission, including observation for =24 hours.	60 months
Secondary	Emergency Department/ Observation Unit Visit	Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours.	60 months
Secondary	Cardiovascular/Cerebrovascular event	Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event	60 months
Secondary	New Onset Diabetes	Diagnosis of diabetes as indicated by 1 or more of the following not present at enrollment; Documented diagnosis of diabetes in medical record; Casual (non-fasting) blood glucose > 200 mg/dL c) Fasting blood glucose > 126 mg/dL d) 2 hour glucose > 200 after oral glucose tolerance test e) chronic use (>6 mos) hypoglycemic therapy outside of pregnancy f) Hemogloblin A1C >= 6.5%	60 months