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A research group led by professor Yusuke Suzuki and professor Hitoshi Suzuki, Department of Nephrology, Faculty of Medicine, Juntendo University (JAPAN) reported their research result which suggests that urinary Galactose-Deficient IgA1 (Gd-IgA1) may become a candidate of useful disease specific biomarker for early stage screening and judgment of severity of IgA nephropathy (IgAN) under collaborative research with Division of Nephrology, Department of Internal Medicine, College of Medicine, Kyung Hee University (KOREA) and Division of Nephrology, Kaohsiung Medical University Hospital (TAIWAN).  

【Measurement of Urinary Gd-IgA1】

In the collaborative research, urinary Gd-IgA1 was measured and evaluated its usefulness in 2 separate groups of patient samples (IgAN and Other kidney diseases) which were obtained under cohort researches conducted by each country.

（IgAN Patient Group）
The group of patients urine samples which were obtained from biopsy-proven IgAN patients.    
338 (Japanese)
69 （Korean）
35（Taiwanese）

（DC Group - Other disease Control Group）
The group of urine samples which were obtained from other kidney disease patients.
120（Japanese）*1
39（Korean）*2

*1 ANCA-associated glomerulonephritis, Lupus nephritis, Minimal change disease（MCD）, Membranous nephropathy (MN), Membranoproliferative glomerulonephritis（MPGN）, Non-IgA mesangial proliferative glomerulonephritis, Focal segmental glomerulosclerosis (FSGS), Tubulointerstitial nephritis（TIN）、Renal amyloidosis, Diabetic kidney disease (DKD), Nephrosclerosis
Tin basement membrane disease (TBMD）

*2 ANCA-associated glomerulonephritis, Lupus nephritis, Minimal change disease（MCD）, Tin basement membrane disease (TBMD） 

【Results】

Urinary Gd-IgA1 value of Japanese and Korean IgAN group was higher than DC group, and urinary Gd-IgA1 value of Korean and Taiwanese IgAN group was higher than Japanese one. 

Urinary Gd-IgA1 value of Japanese IgAN patient was significantly correlated with histological severity of IgAN patients and it was elevated in cases with mild proteinuria.

As the result of analysis with setting the threshold value of urinary Gd-IgA1 as > 50ng/mL, it was correlated with T-Score of MEST-C Oxford classification (Tubular atrophy, interstitial fibrosis）. It was reported that T score of MEST-C Oxford classification is associated with poor prognosis of nephropathy by previous researches. 

In the research, it has been suggested that urinary Gd-IgA1 could be a candidate of useful disease specific biomarker for not only early stage screening of IgAN but also judgement of severity of IgAN because it was observed the correlation with T score of MEST-C Oxford classification which related to poor prognosis of nephropathy. 

【About IgAN】

IgAN has been considered as the most common primary glomerulonephritis and according to 40 world research reports, the morbidity rate of global IgAN has been reported as 2.5 in 100,000 per year. In untreated cases, the prognosis is poor, and it has been also reported that approx. 20 to 40% of untreated patients develop end stage kidney failure within 20 years after onset.

Gd-IgA1 is recognized by anti-glycan autoantibody, and as the result it forms pathogenic immuno-complex, then it is accumulated in kidneys and induces glomerular dysfunction by stimulating mesangium cells.

Renal biopsy is definitive diagnostic method of nephropathy, however, it cannot be conducted number of times because of its invasiveness. It is also confirmed as IgAN by renal biopsy even if patients have no clear proteinuria. So that it has been suggested that value of proteinuria is insufficient index for treatment based on the aspect that it does not always reflect disease activity.

If IgAN can be detected and treated in early stage, it can lead to clinical recovery from IgAN. Therefore non-invasive disease-specific marker is needed which allows early screening, early diagnosis, and determination of the severity of IgAN in clinical practice.

Please refer to the original article below for more information.

Y Fukao et al. Galactose-Deficient IgA1 as a Candidate Urinary Marker of IgA Nephropathy. J Clin Med. 2022 Jun 2;11(11):3173. 
PMID: 35683557

Our ELISA kit, #27600 Gd-IgA1 (Galactose-deficient IgA1) Assay Kit - IBL used Gd-IgA1 specific antibody (KM55) is used for measurement of urine Gd-IgA1 in this research. 

【Related product】
#10777 Anti-Human Gd-IgA1(KM55) Rat IgG MoAb

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