Complete and partial remission as surrogate end points in membranous nephropathy

Aliza Thompson, Daniel C. Cattran, Melanie Blank, Patrick H. Nachman

Research output: Contribution to journalArticlepeer-review

34 Scopus citations

Abstract

Absent a remission of proteinuria, primary membranous nephropathy (MN) can lead to ESRD over many years. Therefore, use of an earlier end point could facilitate the conduct of clinical trials. This manuscript evaluates complete remission (CR) and partial remission (PR) of proteinuria as surrogate end points for a treatment effect on ESRDin patients with primaryMNwith heavy proteinuria. CR is associatedwith a low relapse rate and excellent long-term renal survival, and it plausibly reflects remission of the disease process that leads to ESRD. Patients who achieve PR have better renal outcomes than those who do not but may have elevated relapse rates. How long PR must be maintained to yield a benefit on renal outcomes is also unknown. Hence, available data suggest that CR could be used as a surrogate end point in primary MN, whereas PR seems reasonably likely to predict clinical benefit. In the United States, surrogate end points that are reasonably likely to predict clinical benefit can be used as a basis for accelerated approval; treatments approved under this program must verify the clinical benefit in postmarketing trials. Additional analyses of the relationship between treatment effects on CR and PR and subsequent renal outcomes would inform the design of future clinical trials in primary MN.

Original languageEnglish (US)
Pages (from-to)2930-2937
Number of pages8
JournalJournal of the American Society of Nephrology
Volume26
Issue number12
DOIs
StatePublished - Dec 2015
Externally publishedYes

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