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Nephrology case studies

Establishing Proteinuria as a Surrogate End Point in C3G and Primary IC-MPGN

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Case Study:

Establishing Proteinuria as a Surrogate End Point in C3G and Primary IC-MPGN

 

The Client

Our client is dedicated to developing and delivering treatments for rare kidney diseases, including C3 Glomerulopathy (C3G) and Primary Immune Complex–Mediated Membranoproliferative Glomerulonephritis (IC-MPGN).

 

Background

Proteinuria is a commonly used as an endpoint in clinical trials involving C3G and primary IC-MPGN, as the use of kidney failure rates is neither ethical nor feasible due to its long timeframe. However, the recognition of proteinuria as a validated endpoint by regulatory bodies remains limited, despite growing evidence supporting its prognostic value as a surrogate biomarker for kidney failure.

Opportunity

There was an opportunity to establish consensus on the clinical relevance of proteinuria as a prognostic marker and treatment endpoint in C3G and primary IC-MPG, supporting both clinical trial insights and the real-world management of these rare kidney diseases.

 

Approach

Triducive designed a Delphi approach to engage nephrologists and kidney pathologists in Europe on the clinical relevance of endpoints including proteinuria, eGFR, and glomerular C3 deposition.

 

Our Process

Step 1

A group discussion with experts in C3G and primary IC-MPGN from Europe and Canada was facilitated to discuss treatment efficacy endpoints, endpoints currently used in clinical trials, and the role of proteinuria. They created a set of 31 statements to be tested across a wider audience.

Step 2

A structured online survey was created and disseminated across Europe to survey a larger base of experts in rare kidney diseases. The online survey tested the strength of agreement in relation to the statements developed by the steering group. The steering group then refined the statements that did not reach agreement in the first round. A second round of survey was launched to reach consensus on the remaining 12 statements.

Step 3

The steering group reviewed the survey results and agreed on four notable statements as key findings, selected as recommendations to guide the future management of C3G and primary IC-MPGN.

 

Step 4

A manuscript capable of peer-reviewed publication was developed and authored by the steering group. Triducive supported submission to Kidney International Reports.

Outcomes and Observations

51

responses achieved from rare kidney disease experts across Europe 

4

clear recommendations to guide the future management of C3G and primary IC-MPGN

Kidney International Reports

Published in a high impact peer-reviewed journal which supports credibility and citation of subsequent materials

>>

Provided a strong framework to support clinical trial insights and the management of C3G and primary IC-MPGN

 

Testimonials

“This will hopefully transform patient care in the UK”
Consultant Respiratory Physician, UK
“I would like to express my deep gratitute for your team’s wonderful achievements”
Professor in Cardiovascular Immunology, South Korea
“They understand the scope of the work and what we are trying to achieve with what we're doing”
Professor of Pulmonary Medicine, Canada
“In my experience, you have done the most outstanding work”
Project Manager, Global Healthcare Company, Japan
“There is now so much weight of opinion that payers don’t have any reason to say 'no'”
Brand Director, Global Pharma Company, EU
“This will add to the evidence base that will inform future practice across the the EU”
Cardiothoracic Surgeon, Italy
“A great support to transform future surgery across the EU”
Chair, ETST
“This now provides clear focus in an area that has been confused for a long time”
Microbiologist, Germany
“We remember how unusually excellent you were in this project”
Global Medical Affairs Director, Global Pharma Company, UK
“A great piece of work”
Patient Organisation Leader
“They’ve managed to facilitate a publication in a really high impact journal that's gonna make a difference to the management of patients, not just for clinicians like me in the UK but also around the world”  
Professor of Renal Medicine, UK
“What a fantastic job you have all done”
Haematologist, UK

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