GloMY - Proteinuria in glomerulonephritis : Myfortic

• Research type

  Research Study

• Full title

  RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS.

• IRAS ID

  29421

• Contact name

  lorraine harper

• Eudract number

  2009-016003-26

• ISRCTN Number

  TBC

• Research summary

  GloMY is a UK, multi-centre, randomised controlled open-label pilot trial of myfortic plus short course steroids (prednisolone) versus high-dose prolonged course steroids (prednisolone) in patients with proteinuric primary FSGS and or no additional treatment IgA nephropathy. Currently standard care is high-dose steroids for patients with FSGS, and no treatment for patients with IgAN. The aim is to determine the feasibility of running a larger phase 3 and to obtain preliminary data on the efficacy of myfortic plus short course steroids in inducing sustained response in this patient group. Patients with new onset biopsy proven primary FSGS or IgA nephropathy will be approached in the clinic. If suitable and after they have given written consent they will be randomised to one of two treatment arms, either myfortic and short course steroids or standard care which is high-dose steroids until remission ( maximum 6 months) in FSGS or no immunosuppresison in IgA nephropathy. The primary measure of efficacy will be the proportion of patients achieving complete or partial remission by 24 weeks sustained for 12 months. Data will also be collected on corticosteroid doses, including patients developing steroid induced complications. There will be a maximum of 18 study visits coinciding with routine clinic visits. At the beginning and end of the study, patients will have tests to measure renal disease progression. These will include a renal biopsy at 2 years following start of treatment and biomarker urine tests at the beginning 1 and 2 years of the study. Patients will be given a separate consent form for the biopsy. Otherwise clinical care will be according to routine practice. The study is being sponsored by UHB NHS Foundation Trust.

• REC name

  West of Scotland REC 1

• REC reference

  10/S0703/27

• Date of REC Opinion

  6 May 2010

• REC opinion

  Favourable Opinion