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Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome.

Publication ,  Journal Article
Cho, ME; Branton, MH; Smith, DA; Bartlett, L; Howard, L; Reynolds, JC; Rosenstein, D; Sethi, S; Nava, MB; Barisoni, L; Fervenza, FC; Kopp, JB
Published in: Am J Nephrol
2019

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.

Duke Scholars

Published In

Am J Nephrol

DOI

EISSN

1421-9670

Publication Date

2019

Volume

49

Issue

5

Start / End Page

377 / 385

Location

Switzerland

Related Subject Headings

  • Young Adult
  • Urology & Nephrology
  • Remission Induction
  • Pulse Therapy, Drug
  • Nephrotic Syndrome
  • Middle Aged
  • Male
  • Immunosuppressive Agents
  • Humans
  • Glomerulosclerosis, Focal Segmental
 

Citation

APA
Chicago
ICMJE
MLA
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Cho, M. E., Branton, M. H., Smith, D. A., Bartlett, L., Howard, L., Reynolds, J. C., … Kopp, J. B. (2019). Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome. Am J Nephrol, 49(5), 377–385. https://doi.org/10.1159/000497064
Cho, Monique E., Mary H. Branton, David A. Smith, Linda Bartlett, Lilian Howard, James C. Reynolds, Donald Rosenstein, et al. “Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome.Am J Nephrol 49, no. 5 (2019): 377–85. https://doi.org/10.1159/000497064.
Cho ME, Branton MH, Smith DA, Bartlett L, Howard L, Reynolds JC, et al. Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome. Am J Nephrol. 2019;49(5):377–85.
Cho, Monique E., et al. “Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome.Am J Nephrol, vol. 49, no. 5, 2019, pp. 377–85. Pubmed, doi:10.1159/000497064.
Cho ME, Branton MH, Smith DA, Bartlett L, Howard L, Reynolds JC, Rosenstein D, Sethi S, Nava MB, Barisoni L, Fervenza FC, Kopp JB. Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome. Am J Nephrol. 2019;49(5):377–385.
Journal cover image

Published In

Am J Nephrol

DOI

EISSN

1421-9670

Publication Date

2019

Volume

49

Issue

5

Start / End Page

377 / 385

Location

Switzerland

Related Subject Headings

  • Young Adult
  • Urology & Nephrology
  • Remission Induction
  • Pulse Therapy, Drug
  • Nephrotic Syndrome
  • Middle Aged
  • Male
  • Immunosuppressive Agents
  • Humans
  • Glomerulosclerosis, Focal Segmental