Dataset Information

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

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 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.

SUBMITTER: Cho ME

PROVIDER: S-EPMC6677391 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

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

Cho Monique E ME Branton Mary H MH Smith David A DA Bartlett Linda L Howard Lilian L Reynolds James C JC Rosenstein Donald D Sethi Sanjeev S Nava M Berenice MB Barisoni Laura L Fervenza Fernando C FC Kopp Jeffrey B JB

American journal of nephrology 20190409 5

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 30965344

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Project description:IntroductionThere is a scarcity of research comparing the efficacy of cyclophosphamide and mycophenolate mofetil in childhood nephrotic syndrome. The aim was to evaluate the efficacy and safety of oral cyclophosphamide (CYC) and mycophenolate mofetil (MMF) in children with steroid-sensitive nephrotic syndrome in terms of the proportion of children who have been off steroids for at least 6 months without proteinuria (responders).MethodsThis open-label retrospective-prospective comparative study was conducted in a pediatric nephrology clinic of a referral center for children between 1 and 18 years of age with FR/SD nephrotic syndrome. Group A consisted of patients who received oral cyclophosphamide (100, 25% female) at a dose of 2-2.5 mg/kg once daily for a period of 8-12 weeks. Group B consisted of patients who received oral mycophenolate mofetil (n = 61, 18% female) (dose: 800-1200 mg/m2) for at least 12 months. Responders were defined as children who were off steroids for at least 6 months along with absence of proteinuria.ResultsIn the CYC group, 50% of the patients were responders, whereas 54% of the patients in the MMF group were responders (p = 0.614). The time to first relapse with CYC was 7 months (IQR 5.25-11) compared to 7 months (IQR 3.5-12) with MMF (p = 0.092). The relapse rate in the CYC group was 1.77 relapses per patient-year compared to 1.295 relapses per patient-year in the MMF group. The difference in relapse rate was significant (-0.474; 95% CI, 0.09 to 0.86 relapses/person-year) (p value = 0.009). Multivariate analysis revealed that an age of less than 5 years at the start of treatment was a significant factor for a better response to MMF (p value = 0.039, OR = 2.988, CI -1.055-8.468).ConclusionsThe efficacy of MMF was similar to that of CYC in terms of response (6 months without steroids) in children with FR/SD nephrotic syndrome. MMF showed a favorable response in terms of the frequency of relapse and treatment failure. REGISTRATION OF THE STUDY WITH CLINICAL TRIALS REGISTRY OF INDIA: ( http://ctri.nic.in ;CTRI/2021/06/034421) (Dt: 28/06/2021).

Project description:BackgroundNephrotic syndrome is one of the chronic illnesses in the pediatric age group. The aim of this study was to assess the oral health of patients with steroid-sensitive idiopathic nephrotic syndrome (iNS).MethodsA case-control study was performed on iNS patients and healthy from May 2018 to April 2019. Dental caries was assessed by the World Health Organization criteria, developmental defects of enamel by the mDDE index, oral hygiene by the OHI-S and API, and gingival condition by the GI. Oral health behavior was recorded using a standardized questionnaire including tooth brushing, fluoride prevention, dietary habits and utilization of dental care. Additionally, Streptococcus mutans (SM) and Lactobacillus spp. (LB) bacteria in saliva were assessed using the CRT bacteria test. Statistical analysis comparing oral health parameters was carried by Pearson's chi-squared, Fisher's exact, Shapiro-Wilk verified by Student's t or Mann-Whitney U tests.ResultsThe study included 94 participants of both sexes at the age of 4 to 17 years (47 cases and 47 controls) who were treated in Clinic of Pediatric Nephrology or outpatients' dental clinic in Wroclaw, Poland. The iNS patients compared to the controls revealed some lower caries experience (83.0% vs 95.7%) and number of caries affected primary and/or permanent teeth (4.6 ± 3.5 vs 6.0 ± 4.1), a significantly lower number of filled primary and/or permanent teeth (1.1 ± 1.6 vs 3.5 ± 3.0, P < 0.001) and higher incidence of enamel hypoplasia (31.9% vs 4.3%, P < 0.001). The numbers of the iNS patients with high level of SM and LB were similar to the controls. The iNS patients had a higher OHI-S score (1.89 ± 1.59 vs 1.05 ± 1.02, P < 0.010) and a higher GI score (0.7 ± 1.0 vs 0.3 ± 0.6, P = 0.050). Moreover, they less frequently brushed their teeth twice a day (78.8% vs 93.6%, P = 0.026) and more frequently consumed three or more snacks daily (53.2% vs 23.4%, P = 0.002).ConclusionsThe iNS patients despite the poor oral hygiene revealed lower caries experience but smaller number of restored caries-affected teeth, more severe gingivitis and more frequently teeth affected by enamel hypoplasia.

Dataset Information

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

Background

Methods

Results

Conclusion

Publications

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

Similar Datasets

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