Nephrotic Syndrome in Children Clinical Trial
Official title:
A Multinational Prospective Study on the Duration of Steroid Therapy in Steroid Sensitive Nephrotic Syndrome
Verified date | April 2022 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Idiopathic nephrotic syndrome (INS) is one of the most common glomerular pathologies in children and corticosteroid therapy is its most effective treatment. The total duration of treatment ranges anywhere from two to six months, generally about 3 months. The main objective of our study is to test the feasibility of a shorter total duration (two months) of corticosteroid therapy in patients who show a quicker treatment response to the initial treatment.
Status | Terminated |
Enrollment | 34 |
Est. completion date | October 31, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: - Age 1 to <19 years - Newly diagnosed INS - Patient in remission with steroids - Written informed consent/Assent for the study OR as required by the local IRB Exclusion Criteria: - Age < 1 year or = 19 years - Uncertainty about patient/parent adherence. - Abnormal serum creatinine for patient age - Steroid resistant nephrotic syndrome - Any co-morbid condition that might require modification in treatment with steroids. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai | |
United States | Wayne Pediatrics | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | Children's Hospital of Fudan University |
United States, China,
Bagga A, Hari P, Srivastava RN. Prolonged versus standard prednisolone therapy for initial episode of nephrotic syndrome. Pediatr Nephrol. 1999 Nov;13(9):824-7. — View Citation
Banh TH, Hussain-Shamsy N, Patel V, Vasilevska-Ristovska J, Borges K, Sibbald C, Lipszyc D, Brooke J, Geary D, Langlois V, Reddon M, Pearl R, Levin L, Piekut M, Licht CP, Radhakrishnan S, Aitken-Menezes K, Harvey E, Hebert D, Piscione TD, Parekh RS. Ethnic Differences in Incidence and Outcomes of Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1760-1768. doi: 10.2215/CJN.00380116. Epub 2016 Jul 21. — View Citation
Constantinescu AR, Shah HB, Foote EF, Weiss LS. Predicting first-year relapses in children with nephrotic syndrome. Pediatrics. 2000 Mar;105(3 Pt 1):492-5. — View Citation
Elzouki AY, Amin F, Jaiswal OP. Primary nephrotic syndrome in Arab children. Arch Dis Child. 1984 Mar;59(3):253-5. — View Citation
Hahn D, Hodson EM, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2015 Mar 18;(3):CD001533. doi: 10.1002/14651858.CD001533.pub5. Review. — View Citation
Hiraoka M, Tsukahara H, Matsubara K, Tsurusawa M, Takeda N, Haruki S, Hayashi S, Ohta K, Momoi T, Ohshima Y, Suganuma N, Mayumi M; West Japan Cooperative Study Group of Kidney Disease in Children. A randomized study of two long-course prednisolone regimens for nephrotic syndrome in children. Am J Kidney Dis. 2003 Jun;41(6):1155-62. — View Citation
Hodson EM, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001533. Review. Update in: Cochrane Database Syst Rev. 2015;3:CD001533. — View Citation
Letavernier B, Letavernier E, Leroy S, Baudet-Bonneville V, Bensman A, Ulinski T. Prediction of high-degree steroid dependency in pediatric idiopathic nephrotic syndrome. Pediatr Nephrol. 2008 Dec;23(12):2221-6. doi: 10.1007/s00467-008-0914-y. Epub 2008 Jul 11. — View Citation
Lombel RM, Hodson EM, Gipson DS; Kidney Disease: Improving Global Outcomes. Treatment of steroid-resistant nephrotic syndrome in children: new guidelines from KDIGO. Pediatr Nephrol. 2013 Mar;28(3):409-14. doi: 10.1007/s00467-012-2304-8. Epub 2012 Oct 5. Review. — View Citation
Mattoo TK, Mahmood MA, al-Harbi MS. Nephrotic syndrome in Saudi children clinicopathological study of 150 cases. Pediatr Nephrol. 1990 Sep;4(5):517-9. — View Citation
Sharples PM, Poulton J, White RH. Steroid responsive nephrotic syndrome is more common in Asians. Arch Dis Child. 1985 Nov;60(11):1014-7. — View Citation
Sinha A, Saha A, Kumar M, Sharma S, Afzal K, Mehta A, Kalaivani M, Hari P, Bagga A. Extending initial prednisolone treatment in a randomized control trial from 3 to 6 months did not significantly influence the course of illness in children with steroid-sensitive nephrotic syndrome. Kidney Int. 2015 Jan;87(1):217-24. doi: 10.1038/ki.2014.240. Epub 2014 Jul 16. — View Citation
Srivastava RN, Mayekar G, Anand R, Choudhry VP, Ghai OP, Tandon HD. Nephrotic syndrome in indian children. Arch Dis Child. 1975 Aug;50(8):626-30. — View Citation
Vivarelli M, Moscaritolo E, Tsalkidis A, Massella L, Emma F. Time for initial response to steroids is a major prognostic factor in idiopathic nephrotic syndrome. J Pediatr. 2010 Jun;156(6):965-971. doi: 10.1016/j.jpeds.2009.12.020. Epub 2010 Mar 10. — View Citation
Yoshikawa N, Nakanishi K, Sako M, Oba MS, Mori R, Ota E, Ishikura K, Hataya H, Honda M, Ito S, Shima Y, Kaito H, Nozu K, Nakamura H, Igarashi T, Ohashi Y, Iijima K; Japanese Study Group of Kidney Disease in Children. A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment. Kidney Int. 2015 Jan;87(1):225-32. doi: 10.1038/ki.2014.260. Epub 2014 Jul 23. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first relapse. | The study will evaluate the time in weeks for patients to relapse after completion of initial treatment and if there is any difference between Group A and Group B. | 60-64 weeks | |
Secondary | Number of relapses | Number of relapses per patient after completion of treatment. | 52 weeks | |
Secondary | Number of frequent relapses | Number of frequent relapses per patient after completion of treatment. | 52 weeks | |
Secondary | Number of patients with steroid dependence | Number of patients who show steroid dependence after completion of treatment. | 52 weeks | |
Secondary | Number of patients with late steroid resistance | Number of patients who show late steroid resistance after completion of treatment. | 52 weeks | |
Secondary | Cumulative steroid dose in two groups | The total dose of corticosteroids received in Group A patients versus Group B patients | 60 to 64 weeks | |
Secondary | Number of episodes of upper respiratory infection (URI) and other infections. | The total number of URI or other infections in Group A patients versus Group B patients after completion of treatment. | 52-weeks | |
Secondary | Weight profile | Weight profile in Group A patients versus Group B patients | 60-64 weeks | |
Secondary | Height Profile | Height profile in Group A patients versus Group B patients | 60-64 weeks |
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