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@article{Medjeral-Thomas:2020:10.2215/CJN.06180519,
author = {Medjeral-Thomas, NR and Lawrence, C and Condon, M and Sood, B and Warwicker, P and Brown, H and Pattison, J and Bhandari, S and Barratt, J and Turner, N and Cook, HT and Levy, JB and Lightstone, L and Pusey, C and Galliford, J and Cairns, TD and Griffith, M},
doi = {10.2215/CJN.06180519},
journal = {Clinical Journal of the American Society of Nephrology},
pages = {209--218},
title = {Randomized, controlled trial of tacrolimus and prednisolone monotherapy for adults with De Novo minimal change disease: a multicenter, randomized, controlled trial},
url = {http://dx.doi.org/10.2215/CJN.06180519},
volume = {15},
year = {2020}
}

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TY  - JOUR
AB  - BACKGROUND AND OBJECTIVES: 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. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 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. RESULTS: 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
AU  - Medjeral-Thomas,NR
AU  - Lawrence,C
AU  - Condon,M
AU  - Sood,B
AU  - Warwicker,P
AU  - Brown,H
AU  - Pattison,J
AU  - Bhandari,S
AU  - Barratt,J
AU  - Turner,N
AU  - Cook,HT
AU  - Levy,JB
AU  - Lightstone,L
AU  - Pusey,C
AU  - Galliford,J
AU  - Cairns,TD
AU  - Griffith,M
DO  - 10.2215/CJN.06180519
EP  - 218
PY  - 2020///
SN  - 1555-9041
SP  - 209
TI  - Randomized, controlled trial of tacrolimus and prednisolone monotherapy for adults with De Novo minimal change disease: a multicenter, randomized, controlled trial
T2  - Clinical Journal of the American Society of Nephrology
UR  - http://dx.doi.org/10.2215/CJN.06180519
UR  - https://www.ncbi.nlm.nih.gov/pubmed/31953303
UR  - https://cjasn.asnjournals.org/content/15/2/209
UR  - http://hdl.handle.net/10044/1/76404
VL  - 15
ER  -

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