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Implementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)

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journal contribution
posted on 18.05.2020, 11:59 by Jonathan Barratt, Brad Rovin, Ulysses Diva, Alex Mercer, Radko Komers

There has been little progress in the development

and regulatory approval of novel therapies for

glomerular diseases. There are several reasons for this

dilemma, including safety and efficacy of tested therapies,

the slowly progressive nature of glomerular

diseases, challenges with clinical trial design, and the

traditional endpoints required by regulatory agencies

for drug labeling. This is compounded by the fact that

most primary glomerular diseases are recognized

internationally as rare diseases. The time required and

feasibility to conduct large-scale phase 3 clinical trials

to evaluate whether a new therapy improves kidney

survival and decreases the development of end-stage

kidney disease (ESKD) is prohibitive, particularly

when that disease is rare. Even using doubling of

serum creatinine concentration, an accepted surrogate

endpoint of ESKD, requires expensive trials with

lengthy follow-up.

Funding

The PROTECT study is supported by Retrophin, Inc., San Diego, CA. Retrophin, Inc. was involved in the trial design and protocol development. Writing support was provided by Lynanne McGuire, PhD, CMPP, of MedVal Scientific Information Services, LLC, and was funded by Retrophin, Inc.

History

Citation

Kidney Int Rep (2019) 4, 1633–1637; https://doi.org/10.1016/j.ekir.2019.08.007

Version

VoR (Version of Record)

Published in

KIDNEY INTERNATIONAL REPORTS

Volume

4

Issue

11

Pagination

1633 - 1637 (6)

Publisher

ELSEVIER SCIENCE INC

issn

2468-0249

eissn

2468-0249

Acceptance date

19/08/2019

Copyright date

2019

Available date

19/08/2019

Publisher version

https://www.kireports.org/article/S2468-0249(19)31463-9/abstract

Notes

The PROTECT study is supported by Retrophin, Inc., San Diego, CA. Retrophin, Inc. was involved in the trial design and protocol development. Writing support was provided by Lynanne McGuire, PhD, CMPP, of MedVal Scientific Information Services, LLC, and was funded by Retrophin, Inc. This trial is registered in the European Union as EudraCT 2017-004605-41 and in the United States as ClinicalTrials.gov NCT03762850.

Spatial coverage

United States

Language

English