Monique E Cho1, Mary H Branton1, David A Smith1, Linda Bartlett1, Lilian Howard1, James C Reynolds2, Donald Rosenstein3, Sanjeev Sethi4, M Berenice Nava1,5, Laura Barisoni6, Fernando C Fervenza7, Jeffrey B Kopp8. 1. Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA. 2. Radiology and Imaging Services, Mark O. Hatfield Clinical Research Center, Bethesda, Maryland, USA. 3. Department of Psychiatry, University of North Carolina, Chapel Hill, North Carolina, USA. 4. Department of Pathology, Mayo Clinic, Rochester, Minnesota, USA. 5. Kaiser Permanente, San Diego, California, USA. 6. Department of Pathology, University of Miami Miller School of Medicine, Miami, Florida, USA. 7. Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA. 8. Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, Maryland, USA, jbkopp@NIH.gov.
Abstract
BACKGROUND: In adults with primary focal segmental glomerulosclerosis (FSGS), daily prednisone may induce complete remissions (CR) and partial remissions (PR), but relapses are frequent and adverse events are common. METHODS: We carried out 2 open-label, uncontrolled trials to explore the efficacy and tolerability of pulse oral dexamethasone as an alternative to daily prednisone. We enrolled adult patients with proteinuria > 3.5 g/day despite the use ofrenin-angiotensin-aldosterone blockade. In the first trial, we enrolled 14 subjects with FSGS and administered 4dexamethasone doses (25 mg/m2) daily for 4 days, repeated every 28 days over 32 weeks. The second trial involved a more intensive regimen. Eight subjects received 4 dexamethasone doses of 50 mg/m2 every 4 weeks for 12 weeks, followed by 4 doses of 25 mg/m2 every 4 weeks for 36 weeks; subjects were randomized to 2 doses every 2 weeks or 4 doses every 4 weeks. RESULTS: In the first trial, we enrolled 13 subjects with FSGS and 1 with minimal change disease and found a combined CR and PR rate of 36%. In the second trial, we enrolled 8 subjects. The combined CR and PR rate was 29%. Analysis combining both trials showed a combined CR and PR rate of 33%. Adverse events were observed in 32% of subjects, with mood symptoms being most common. There were no serious adverse events related to the study. CONCLUSION: We conclude that high dose oral dexamethasone is well tolerated by adults with idiopathic nephrotic syndrome and may have some efficacy. Published by S. Karger AG, Basel.
RCT Entities:
BACKGROUND: In adults with primary focal segmental glomerulosclerosis (FSGS), daily prednisone may induce complete remissions (CR) and partial remissions (PR), but relapses are frequent and adverse events are common. METHODS: We carried out 2 open-label, uncontrolled trials to explore the efficacy and tolerability of pulse oral dexamethasone as an alternative to daily prednisone. We enrolled adult patients with proteinuria > 3.5 g/day despite the use of renin-angiotensin-aldosterone blockade. In the first trial, we enrolled 14 subjects with FSGS and administered 4 dexamethasone doses (25 mg/m2) daily for 4 days, repeated every 28 days over 32 weeks. The second trial involved a more intensive regimen. Eight subjects received 4 dexamethasone doses of 50 mg/m2 every 4 weeks for 12 weeks, followed by 4 doses of 25 mg/m2 every 4 weeks for 36 weeks; subjects were randomized to 2 doses every 2 weeks or 4 doses every 4 weeks. RESULTS: In the first trial, we enrolled 13 subjects with FSGS and 1 with minimal change disease and found a combined CR and PR rate of 36%. In the second trial, we enrolled 8 subjects. The combined CR and PR rate was 29%. Analysis combining both trials showed a combined CR and PR rate of 33%. Adverse events were observed in 32% of subjects, with mood symptoms being most common. There were no serious adverse events related to the study. CONCLUSION: We conclude that high dose oral dexamethasone is well tolerated by adults with idiopathic nephrotic syndrome and may have some efficacy. Published by S. Karger AG, Basel.
Authors: Stéphan Troyanov; Catherine A Wall; Judith A Miller; James W Scholey; Daniel C Cattran Journal: J Am Soc Nephrol Date: 2005-02-16 Impact factor: 10.121
Authors: Louis-Philippe Laurin; Adil M Gasim; Caroline J Poulton; Susan L Hogan; J Charles Jennette; Ronald J Falk; Bethany J Foster; Patrick H Nachman Journal: Clin J Am Soc Nephrol Date: 2016-02-16 Impact factor: 8.237
Authors: T Uzu; T Harada; M Sakaguchi; M Kanasaki; K Isshiki; S Araki; T Sugiomoto; D Koya; M Haneda; A Kashiwagi; A Yamauchi Journal: Nephron Clin Pract Date: 2006-11-29
Authors: C Ponticelli; M Villa; G Banfi; B Cesana; C Pozzi; A Pani; P Passerini; M Farina; C Grassi; A Baroli Journal: Am J Kidney Dis Date: 1999-10 Impact factor: 8.860