Kidney Week

Abstract: TH-PO1021

Mycophenolate Mofetil and Tacrolimus versus Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis: A Randomised Controlled Trial

Session Information

• Glomerular Diseases: Clinical, Outcomes, Trials - I
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

• Nikolopoulou, Aikaterini K., Imperial College London, London, United Kingdom

Aikaterini K. Nikolopoulou,

• Condon, Marie B., St. Helier Hospital, Surrey, United Kingdom

Marie B. Condon,

• Cook, H. Terence, Imperial College London, London, United Kingdom

H. Terence Cook,

• Duncan, Neill D., Imperial College Healthcare NHS Trust, London, United Kingdom

Neill D. Duncan,

• Galliford, Jack W., Imperial College Healthcare NHS Trust, London, United Kingdom

Jack W. Galliford,

• Levy, Jeremy B., Imperial College Healthcare NHS Trust, London, United Kingdom

Jeremy B. Levy,

• Lightstone, Liz, Imperial College London, London, United Kingdom

Liz Lightstone,

• Pusey, Charles D., Imperial College London, London, United Kingdom

Charles D. Pusey,

• Roufosse, Candice A., Imperial College Healthcare NHS Trust, London, United Kingdom

Candice A. Roufosse,

• Cairns, Tom, Imperial College Healthcare NHS Trust, London, United Kingdom

Tom Cairns,

• Griffith, Megan, Imperial College Healthcare NHS Trust, London, United Kingdom

Megan Griffith,

Background

Membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. Tacrolimus (TAC) is effective in inducing remission of proteinuria; however relapses after TAC withdrawal are common. We aimed to investigate if the addition of mycophenolate mofetil (MMF) to TAC reduces the relapse rate of nephrotic syndrome in patients with MN after treatment withdrawal.

Methods

A single centre randomised controlled trial was undertaken from 2008 to 2014; patients with biopsy proven idiopathic MN were recruited and randomly assigned to receive MMF and TAC or TAC alone. Treatment was for 1 year initially; once patients were in remission for 12 months the MMF was stopped and TAC tapered over 6 months in both groups. The primary outcome was the efficacy of MMF in preventing relapse of nephrotic syndrome on withdrawal of TAC.

Results

We randomly assigned 40 patients, 20 of whom received MMF and TAC and 20 received TAC alone. Both groups had similar baseline characteristics. Retrospective anti phospholipase A2 receptor (PLA2R) biopsy staining showed similar PLA2R positivity in both groups. Follow up was until primary endpoint or for a minimum of 3 years. The time to relapse after treatment withdrawal was similar in the two groups. 40% of patients (n=8) in the TAC/MMF group relapsed after treatment withdrawal compared to 35% (n=7) in the TAC group; there was no statistically significant difference in the relapse rate between the two groups (p=0.77). Both treatments were equivalent in achieving remission; 85% of patients in the TAC/MMF group and 75% in the TAC group reached complete remission (p=0.7). There was a trend to earlier remission in the TAC/MMF group; median time to remission 40 weeks compared to 54 weeks with TAC alone, but this was not statistically significant (p=0.46). Both treatments were well tolerated with similar adverse events.

Conclusion

The addition of MMF to TAC did not protect from relapse of nephrotic syndrome due to idiopathic MN compared to treatment with TAC alone; both groups showed similar remission rates and adverse events. The treatment was well tolerated and further studies are needed to investigate if high risk subgroups may benefit from combination therapy.