Indian TrANslational GlomerulonephrItis BioLogy nEtwork (I-TANGIBLE): Design and Methods

Kavita Yadav; Raja Ramachandran; Vinod Kumar; Ashok K Yadav; Deeksha Pal; Natarajan Gopalakrishnan; Sourabh Sharma; P S Priyamvada; Arpita Lahiri; Manisha Sahay; Sree Bhushan Raju; M Sreelatha; R Manorajan; Pinaki Mukhopadhyay; Narayan Prasad; Priti Meena; Harbir S Kohli; Sanjay Vikrant; Vivekanand Jha

doi:10.4103/ijn.ijn_305_23

Indian TrANslational GlomerulonephrItis BioLogy nEtwork (I-TANGIBLE): Design and Methods

Indian J Nephrol. 2023 Jul-Aug;33(4):277-282. doi: 10.4103/ijn.ijn_305_23. Epub 2023 Aug 10.

Authors

Kavita Yadav¹, Raja Ramachandran², Vinod Kumar³, Ashok K Yadav⁴, Deeksha Pal⁵, Natarajan Gopalakrishnan⁶, Sourabh Sharma⁷, P S Priyamvada⁸, Arpita Lahiri⁹, Manisha Sahay¹⁰, Sree Bhushan Raju¹¹, M Sreelatha¹², R Manorajan¹³, Pinaki Mukhopadhyay¹⁴, Narayan Prasad¹⁵, Priti Meena¹⁶, Harbir S Kohli⁵, Sanjay Vikrant¹⁷, Vivekanand Jha^{18

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Affiliations

¹ Chronic Kidney Disease, George Institute for Global Health India, New Delhi, India.
² Departments of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
³ Dermatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
⁴ Experimental Medicine and Biotechnology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
⁵ Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
⁶ Department of Nephrology, Madras Medical College, Chennai, Tamil Nadu, India.
⁷ Department of Nephrology, VMMC and Safdarjung Hospital, New Delhi, India.
⁸ Department of Nephrology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
⁹ Department of Nephrology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
¹⁰ Department of Nephrology, Osmania Medical College, Hyderabad, Telangana, India.
¹¹ Department of Nephrology, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.
¹² Department of Nephrology, Government Medical College, Calicut, Kerala, India.
¹³ Department of Nephrology, Madurai Medical College, Madurai, Tamil Nadu, India.
¹⁴ Department of Nephrology, NRS Medical College, Kolkata, West Bengal, India.
¹⁵ Department of Nephrology, Sanjay Gandhi PGIMS, Lucknow, Uttar Pradesh, India.
¹⁶ Department of Nephrology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
¹⁷ Department of Nephrology, All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India.
¹⁸ Chronic Kidney Disease, George Institute for Global Health India, UNSW, New Delhi, India.
¹⁹ Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka, India.
²⁰ Department of Medicine, School of Public Health, Imperial College, London, UK.

Abstract

Background and aim: Primary glomerular disease accounts for one-sixth of all chronic kidney diseases (CKDs) in India. We remain limited in our ability to effectively treat these conditions because of lack of understanding of the disease mechanisms and lack of predictors to identify the clinical course and therapeutic responsiveness. We propose to develop a network of investigators in glomerular diseases, collect information in a systematic fashion to understand the clinical outcomes, answer translational research questions better, and identify and recruit patients for clinical trials.

Materials and methods: This is a prospective, observational study. The Indian TrANslational GlomerulonephrItis BioLogy nEtwork (I-TANGIBLE) cohort will enroll patients (>18 years) with biopsy-proven minimal change disease (MCD), focal segmental glomerulonephritis (FSGS), membranous nephropathy (MN), IgA nephropathy (IgAN), or membranoproliferative glomerulonephritis (MPGN) (immune complex- and complement-mediated), with first biopsy taken within 2 years of enrollment. Patients with estimated glomerular filtration (eGFR) rate <15 ml/min/1.73 m² for >3 months at the time of screening, kidney transplant or bone marrow transplant recipients, patients with active malignancy, and patients with active hepatitis B/C replication or human immunodeficiency virus (HIV)-I/II will be excluded. Clinical details including history, medication history and details, and family history will be obtained. Consenting patient's blood and urine samples will be collected and stored, aligned to their clinical follow-up.

Expected outcomes: The network will allow accurate ascertainment of disease burden of glomerular diseases across study sites, establishment of the treatment pattern of common glomerular diseases, investigation of medium- and long-term outcomes (remission, relapse, rate of eGFR decline), and building a suitable infrastructure to carry out clinical trials in primary glomerular disease.

Keywords: Focal segmental glomerulonephritis (FSGS); longitudinal cohort; membranoproliferative glomerulonephritis (MPGN); membranous nephropathy (MN); minimal change disease (MCD).