GloMY

GloMY is a randomised pilot trial of Myfortic for the treatment of primary proteinuric glomerulonephritis.

Short Title: Proteinuria in Glomerulonephritis: Myfortic (GloMY)

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The GloMY trial closed to recruitment on Tuesday 21st August 2012.

Chief Investigator: Prof Lorraine Harper

Trial Sponsor: University Hospital Birmingham NHS Foundation Trust

Funding: An Educational Grant from Novartis Pharmaceuticals UK Ltd

West of Scotland REC Ref. No.: 10/S0703/27

ISRCTN11937028

EUDRACT No: 2009- 016003-26

GloMY Design:

GloMY is a national, multi-centre, randomised controlled open-label pilot trial of Myfortic plus short course steroids versus standard care in patients with proteinuric primary focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN). Currently standard care is a long course of steroids for patients with FSGS, and no treatment for patients with IgAN.

GloMY Aim:

To determine the feasibility of running a full-scale phase III randomised trial of Myfortic plus short course steroids versus standard care in patients with FSGS or IgAN, and to obtain preliminary comparative data on the efficacy of Myfortic plus short course steroids in inducing sustained response in patients with FSGS or IgAN.

GloMY Sample Size:

As this is a pilot study, no formal sample size calculations have been performed. Recruitment of 100 patients with FSGS and IgAN over 24 months was planned (50 to Myfortic with short course steroids and 50 to standard care), with a minimum number of 40 patients with each disease type. GloMY closed to recruitment on 21st Aug 2012 with 12 patients randomised and 26 centres fully approved.

GloMY Study Duration:

48 months