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Therefore, since we have been justified by faith, we have peace with God through our Lord Jesus Christ. Through him we have also obtained access by faith into this grace in which we stand, and we rejoice in hope of the glory of God. Romans 5:1–2

GRACE (Glomerular Research And Clinical Experiments)

World’s First Platform Trial for Glomerular Disease: Advancing IgA Nephropathy Treatment Through Patient-Centric and Pragmatic Clinical Trial

Randomized Embedded Adaptive Platform Clinical Trial in South Asian Kidney Biopsy-Proven Primary Glomerular Diseases: Multi-center, Multi-arm and Multi-stage

Chronic Kidney Disease: A Growing Public Health Crisis

Chronic Kidney Disease (CKD) is now the 12th leading cause of death worldwide, with a 20% increase in mortality over the past decade. It has reached epidemic proportions in South Asia, impacting about 1 in 7 adults (GBD, 2017; Shrestha, 2021; Alexander, 2021).

In this region, glomerular diseases are the most common cause of CKD after diabetes and high blood pressure. Among these, IgA Nephropathy (IgAN) is the most prevalent primary glomerular disease in adults.

Kidney disease in South Asians

Our prospective longitudinal observational ‘Glomerular Research And Clinical Experiments- IgA Nephropathy in Indians’ (GRACE-IgANI) cohort since 2015, by Alexander et al., showed significant progression of IgA Nephropathy over 3 years.

Having a rapid fall in eGFR

39%

Non-remission of proteinuria

25%

Adverse kidney outcome at three years

36%

Our group has shown that South Asian ethnicity is associated with a severe phenotype, rapid progression, and significant ethnic differences in biomarkers in the first prospective longitudinal IgAN (GRACE-IgANI) cohort.

Why GRACE IgAN Trial?

South Asian population has shown severe IgAN phenotype and faster disease progression compared to other regions. With limited access to affordable treatment, there’s a need for evidence-based interventions that are accessible and effective.

This trial also establishes the GRACE Clinical Trial Network – a platform for collaborative, adaptive, and pragmatic clinical research in glomerular diseases across South Asia.

Trial Design & Goal

Design: Multi-Arm Multi-Stage (MAMS) Platform Trial

Tests multiple interventions simultaneously
Shares a concurrent Standard of Care (SoC) group
Allows new interventions to be added over time
Uses interim analysis to stop ineffective treatments early
Based on real-world nephrology practice

Goal: To find effective intervention that can delay disease progression or prevent kidney failure in adults with biopsy-confirmed IgAN in South Asian population.

Trial Registration

ClinicalTrials.gov – NCT06676384

CTRI (India) –CTRI/2024/11/076794

Trial Sample Size

Aims to recruit 585 participants with Primary IgA Nephropathy

First participant randomized on 16 February 2025 in CMC Vellore

Funded by

Therefore, since we have been justified by faith, we have peace with God through our Lord Jesus Christ. Through him we have also obtained access by faith into this grace in which we stand, and we rejoice in hope of the glory of God. Romans 5:1–2

Welcome to

GRACE (Glomerular Research And Clinical Experiments)

World’s First Platform Trial for Glomerular Disease: Advancing IgA Nephropathy Treatment Through Patient-Centric and Pragmatic Clinical Trial

Randomized Embedded Adaptive Platform Clinical Trial in South Asian Kidney Biopsy-Proven Primary Glomerular Diseases: Multi-center, Multi-arm and Multi-stage

Chronic Kidney Disease: A Growing Public Health Crisis

Chronic Kidney Disease (CKD) is now the 12th leading cause of death worldwide, with a 20% increase in mortality over the past decade. It has reached epidemic proportions in South Asia, impacting about 1 in 7 adults (GBD, 2017; Shrestha, 2021; Alexander, 2021).

In this region, glomerular diseases are the most common cause of CKD after diabetes and high blood pressure. Among these, IgA Nephropathy (IgAN) is the most prevalent primary glomerular disease in adults.

Kidney disease in South Asians

Our prospective longitudinal observational ‘Glomerular Research And Clinical Experiments- IgA Nephropathy in Indians’ (GRACE-IgANI) cohort since 2015, by Alexander et al., showed significant progression of IgA Nephropathy over 3 years.

Our group has shown that South Asian ethnicity is associated with a severe phenotype, rapid progression, and significant ethnic differences in biomarkers in the first prospective longitudinal IgAN (GRACE-IgANI) cohort.

Why GRACE IgAN Trial?

South Asian population has shown severe IgAN phenotype and faster disease progression compared to other regions. With limited access to affordable treatment, there’s a need for evidence-based interventions that are accessible and effective.

This trial also establishes the GRACE Clinical Trial Network – a platform for collaborative, adaptive, and pragmatic clinical research in glomerular diseases across South Asia.

Trial Design & Goal

Design: Multi-Arm Multi-Stage (MAMS) Platform Trial

Tests multiple interventions simultaneously

Shares a concurrent Standard of Care (SoC) group

Allows new interventions to be added over time

Uses interim analysis to stop ineffective treatments early

Based on real-world nephrology practice

Goal: To find effective intervention that can delay disease progression or prevent kidney failure in adults with biopsy-confirmed IgAN in South Asian population.

ClinicalTrials.gov – NCT06676384

CTRI (India) –CTRI/2024/11/076794

Trial Sample Size

Aims to recruit 585 participants with Primary IgA Nephropathy

First participant randomized on 16 February 2025 in CMC Vellore

DBT/Wellcome Trust India Alliance,
Nishant House, 8-2-351/N/1, 2nd floor,
Road No. 2, Venkateshwara Hills, Banjara Hills,
Hyderabad – 500034

Principal Coordinating Center

Christian Medical College, Vellore
Ranipet Campus, Kilminnal Village,
Ranipet District, Vellore – 632517
Tamil Nadu, India

Trial Statistical Oversight

MRC Clinical Trials Unit, UCL, London

Therefore, since we have been justified by faith, we have peace with God through our Lord Jesus Christ. Through him we have also obtained access by faith into this grace in which we stand, and we rejoice in hope of the glory of God. Romans 5:1–2

Welcome to

GRACE (Glomerular Research And Clinical Experiments)

World’s First Platform Trial for Glomerular Disease: Advancing IgA Nephropathy Treatment Through Patient-Centric and Pragmatic Clinical Trial

Randomized Embedded Adaptive Platform Clinical Trial in South Asian Kidney Biopsy-Proven Primary Glomerular Diseases: Multi-center, Multi-arm and Multi-stage

Chronic Kidney Disease: A Growing Public Health Crisis

Chronic Kidney Disease (CKD) is now the 12th leading cause of death worldwide, with a 20% increase in mortality over the past decade. It has reached epidemic proportions in South Asia, impacting about 1 in 7 adults (GBD, 2017; Shrestha, 2021; Alexander, 2021).

In this region, glomerular diseases are the most common cause of CKD after diabetes and high blood pressure. Among these, IgA Nephropathy (IgAN) is the most prevalent primary glomerular disease in adults.

Kidney disease in South Asians

Our prospective longitudinal observational ‘Glomerular Research And Clinical Experiments- IgA Nephropathy in Indians’ (GRACE-IgANI) cohort since 2015, by Alexander et al., showed significant progression of IgA Nephropathy over 3 years.

Our group has shown that South Asian ethnicity is associated with a severe phenotype, rapid progression, and significant ethnic differences in biomarkers in the first prospective longitudinal IgAN (GRACE-IgANI) cohort.

Why GRACE IgAN Trial?

South Asian population has shown severe IgAN phenotype and faster disease progression compared to other regions. With limited access to affordable treatment, there’s a need for evidence-based interventions that are accessible and effective.

This trial also establishes the GRACE Clinical Trial Network – a platform for collaborative, adaptive, and pragmatic clinical research in glomerular diseases across South Asia.

Trial Design & Goal

Design: Multi-Arm Multi-Stage (MAMS) Platform Trial

Tests multiple interventions simultaneously

Shares a concurrent Standard of Care (SoC) group

Allows new interventions to be added over time

Uses interim analysis to stop ineffective treatments early

Based on real-world nephrology practice

Goal: To find effective intervention that can delay disease progression or prevent kidney failure in adults with biopsy-confirmed IgAN in South Asian population.

ClinicalTrials.gov – NCT06676384

CTRI (India) –CTRI/2024/11/076794

Trial Sample Size

Aims to recruit 585 participants with Primary IgA Nephropathy

First participant randomized on 16 February 2025 in CMC Vellore

DBT/Wellcome Trust India Alliance, Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad – 500034

Principal Coordinating Center

Christian Medical College, Vellore Ranipet Campus, Kilminnal Village,Ranipet District, Vellore – 632517 Tamil Nadu, India

Trial Statistical Oversight

MRC Clinical Trials Unit, UCL, London

DBT/Wellcome Trust India Alliance,
Nishant House, 8-2-351/N/1, 2nd floor,
Road No. 2, Venkateshwara Hills, Banjara Hills,
Hyderabad – 500034

Christian Medical College, Vellore
Ranipet Campus, Kilminnal Village,
Ranipet District, Vellore – 632517
Tamil Nadu, India