A study to compare effectiveness of Body-weight based vs Body-surface area based prednisolone regimen in children with nephrotic syndrome, a chronic protein losing kidney disease.
- Conditions
- Nephrotic Syndrome
- Registration Number
- CTRI/2015/03/005655
- Lead Sponsor
- NRS Medical College and Hospital
- Brief Summary
Nephrotic syndrome (NS) is a common chronic renal disorder encountered in children. Idiopathic NS responds well to corticosteroid therapy with remission of proteinuria. A dose of 60 mg/m² body surface area per day of prednisolone is the recommendation for initial therapy of NS as per the International Study of Kidney Disease in Children (ISKDC) [1] and has been followed in several studies [2]. Several studies as well as Indian guidelines on management of steroid sensitive NS recommend 2 mg/kg body weight per day as initial starting dosage [3, 4]. Some authors recommend either body weight- based prednisolone or body surface area-based prednisolone regimen assuming both would be equivalent [5]. A recent study by Faber *et al* has shown that both the dosages are not equivalent as per cumulative dosing, especially when body weight is less than 30 kg and /or the total prednisolone dose is less than 60 mg/day; and recommended further studies to assess the clinical significance and outcome of children in response to both dosing in terms of time taken for remission, number of relapses and complications due to steroid therapy [6]. A retrospective study by Saadeh *et al* [7] has described the clinical effects of weight-based relative under dosing of prednisolone: while the initial response was not influenced by such under dosing, the frequency of relapses during the first 6 months appeared to be higher in this relatively under dosed group. They also recommended future prospective studies directly comparing outcomes of childhood NS with weight-based or body surface area-based dosing to confirm the findings of their study. Hence we propose to conduct the present randomized controlled trial to analyze the clinical significance of body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with NS.
***REFERENCES***
1. Nephrotic syndrome in children: a randomized trial comparing two prednisone regimens in steroid-responsive patients who relapse early. Report of the international study of kidney disease in children. J Pediatr. 1979 Aug;95(2):239-43.
2. Hoyer PF, Brodeh J. Initial treatment of idiopathic nephrotic syndrome in children: prednisone versus prednisone plus cyclosporine A: a prospective, randomized trial. J Am Soc Nephrol. 2006 Apr;17(4):1151-7.
3. Ekka BK, Bagga A, Srivastava RN. Single- versus divided-dose prednisolone therapy for relapses of nephrotic syndrome. Pediatr Nephrol. 1997 Oct;11(5):597-9.
4. Bagga A, Ali U, Banerjee S, Kanitkar M, Phadke KD, Senguttuvan P, Sethi S, Shah M. Management of steroid sensitive nephrotic syndrome: revised guidelines. Indian Pediatr. 2008 Mar;45(3):203-14.
5. Hodson EM, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001533.
6. Feber J, Al-Matrafi J, Farhadi E, Vaillancourt R, Wolfish N. Prednisone dosing per body weight or body surface area in children with nephrotic syndrome: is it equivalent? Pediatr Nephrol. 2009 May;24(5):1027-31.
7. Saadeh SA, Baracco R, Jain A, Kapur G, Mattoo TK, Valentini RP. Weight or body surface area dosing of steroids in nephrotic syndrome: is there an outcome difference? Pediatr Nephrol. 2011 Dec;26(12):2167-71.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
(1) Age-2 to 12years (2) Idiopathic Nephrotic Syndrome (3) Either first episode nephritic syndrome or infrequent relapse nephrotic syndrome.
(1)Congenital nephrotic syndrome (2)Previous history of receiving any immunosuppressant other than prednisolone (3)Steroid resistant nephritic syndrome (4)Steroid dependant nephrotic syndrome (5)Secondary causes of nephrotic syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse free survival over 6 months 3 and 6 month
- Secondary Outcome Measures
Name Time Method Time taken for initial remission, adverse effects of steroids, cumulative dosage of prednisolone. 3 and 6 month
Trial Locations
- Locations (1)
Room No.16, Div. of Pediatric Nephrology and OPD, Dept. of Pediatrics, NRS Medical College
🇮🇳Kolkata, WEST BENGAL, India
Room No.16, Div. of Pediatric Nephrology and OPD, Dept. of Pediatrics, NRS Medical College🇮🇳Kolkata, WEST BENGAL, IndiaShilpita BaruaPrincipal investigator89577566886jasminebarua87@gmail.com