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Clin J Am Soc Nephrol. 2020 Feb 7;15(2):209-218. doi: 10.2215/CJN.06180519. Epub 2020 Jan 17.

Randomized, Controlled Trial of Tacrolimus and Prednisolone Monotherapy for Adults with De Novo Minimal Change Disease: A Multicenter, Randomized, Controlled Trial.

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Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.
The Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom.
South West Thames Renal and Transplantation Unit, Epsom and St Helier University Hospitals NHS Trust, Epsom, United Kingdom.
Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.
Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, United Kingdom.
Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom; and.
Centre for Inflammatory Disease, Imperial College London, London, United Kingdom.
Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom;



Minimal change disease is an important cause of nephrotic syndrome in adults. Corticosteroids are first-line therapy for minimal change disease, but a prolonged course of treatment is often required and relapse rates are high. Patients with minimal change disease are therefore often exposed to high cumulative corticosteroid doses and are at risk of associated adverse effects. This study investigated whether tacrolimus monotherapy without corticosteroids would be effective for the treatment of de novo minimal change disease.


This was a multicenter, prospective, open-label, randomized, controlled trial involving six nephrology units across the United Kingdom. Adult patients with first presentation of minimal change disease and nephrotic syndrome were randomized to treatment with either oral tacrolimus at 0.05 mg/kg twice daily, or prednisolone at 1 mg/kg daily up to 60 mg daily. The primary outcome was complete remission of nephrotic syndrome after 8 weeks of therapy. Secondary outcomes included remission of nephrotic syndrome at 16 and 26 weeks, rates of relapse of nephrotic syndrome, and changes from baseline kidney function.


There were no significant differences between the tacrolimus and prednisolone treatment cohorts in the proportion of patients in complete remission at 8 weeks (21 out of 25 [84%] for prednisolone and 17 out of 25 [68%] for tacrolimus cohorts; P=0.32; difference in remission rates was 16%; 95% confidence interval [95% CI], -11% to 40%), 16 weeks (23 out of 25 [92%] for prednisolone and 19 out of 25 [76%] for tacrolimus cohorts; P=0.25; difference in remission rates was 16%; 95% CI, -8% to 38%), or 26 weeks (23 out of 25 [92%] for prednisolone and 22 out of 25 [88%] for tacrolimus cohorts; P=0.99; difference in remission rates was 4%; 95% CI, -17% to 25%). There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission (P=0.99) or in the time from complete remission to relapse.


Tacrolimus monotherapy can be effective alternative treatment for patients wishing to avoid steroid therapy for minimal change disease.


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Glomerulonephritis; United Kingdom; adult; humans; lipoid nephrosis; nephrology; nephrotic syndrome; prednisolone; prospective studies; recurrence; remission induction; tacrolimus; treatment outcome


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