Protocol and rationale for the first South Asian 5-year prospective longitudinal observational cohort study and biomarker evaluation investigating the clinical course and risk profile of IgA nephropathy: GRACE IgANI cohort

Wellcome Open Research

article

Suceena Alexander¹  George T. John²  Anila Korula³  T. S. Vijayakumar¹  Vinoi George David¹  Anjali Mohapatra¹  Anna T. Valson¹  Shibu Jacob¹  Pradeep Mathew Koshy¹  Gautam Rajan¹  Elenjickal Elias John¹  Smita Mary Matthai⁴  L. Jeyaseelan⁵  Babu Ponnusamy⁶  Terence Cook⁷  Charles Pusey⁸  Mohamed R. Daha⁹  John Feehally^1,10  Jonathan Barratt^1,10  Santosh Varughese¹ 

[1] Department of Nephrology, Christian Medical College;Department of Renal Medicine, Royal Brisbane and Women's Hospital;Department of General Pathology, Christian Medical College;Central Electron Microscope Unit, Christian Medical College;Department of Biostatistics, Christian Medical College;Centre for Cellular and Molecular Platforms;Centre for Complement and Inflammation Research, Imperial College;Department of Medicine, Imperial College Healthcare NHS Trust;Rijksuniversiteit Groningen Faculteit Biologie;University of Leicester, College of Medicine Biological Sciences and Psychology

关键词: Immunology;    Nephrology;    IgA nephropathy;    Glomerulonephritis;    Pathology;    South-Asians;    Indians;    Epidemiology;    Protocol;   

DOI  :  10.12688/wellcomeopenres.14644.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: IgA nephropathy (IgAN) is the most common primary glomerulonephritis and an important cause of end-stage kidney disease. Unlike the slowly progressive course seen among Caucasian and East Asian subjects (actuarial survival 80-85% over 10 years), in India about 30-40% of patients have nephrotic syndrome and renal dysfunction at presentation and a 10-year renal survival of 35%, as reported from a retrospective registry. These observations cannot be entirely attributed to a lack of uniform screening protocols or late referral and attest to the probability that IgAN may not be the same disease in different parts of the world.Methods: We will prospectively recruit 200 patients with IgAN (the GRACE IgANI—GlomerularResearchAndClinicalExperiments-IgANephropathy inIndians—cohort) and stratify them into low and high risk of progression based on published absolute renal risk scores. We will test the validity of this risk score in an unselected Indian IgAN population over a 5-year follow-up period. In parallel, we will undertake extensive exploratory serum, urine, renal and microbiome biomarker studies, firstly, to determine if the underlying pathogenic pathways are the same in Indian IgAN compared to those reported in Caucasian and East Asian IgAN. Secondly, we will systematically assess the value of measuring selected biomarkers and adding this data to traditional measures of risk in IgAN to predict kidney failure. We ultimately hope to generate a composite IgAN risk score specific for the Indian population.Ethics and data dissemination: Approval was obtained from the Institutional Review Board (Silver, Research and Ethics Committee) of the Christian Medical College, Vellore, India (Ref. No. IRB Min. No. 8962 [Other] dated 23.07.2014 and IRB Min. No. 9481 [Other] dated 24.06.2015). It is anticipated that results of this study will be presented at national and international meetings, with reports being published from late 2018.

【 授权许可】

CC BY