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CTRI Number  CTRI/2015/03/005655 [Registered on: 27/03/2015] Trial Registered Prospectively
Last Modified On: 23/03/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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.  
Scientific Title of Study   Efficacy of Body-weight based vs Body-surface area based prednisolone regimen in Idiopathic Nephrotic Syndrome: A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpita Barua 
Designation  Trainee 
Affiliation  NRS Medical College and Hospital 
Address  Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata WEST BENGAL 700014

Kolkata
WEST BENGAL
700014
India 
Phone    
Fax    
Email  jasminebarua87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Biswanath Basu  
Designation  Assistant Professor and In charge, Division of Pediatric Nephrology  
Affiliation  NRS Medical College and Hospital 
Address  Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata WEST BENGAL 700014

Kolkata
WEST BENGAL
700014
India 
Phone    
Fax    
Email  basuv3000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Biswanath Basu  
Designation  Assistant Professor and In charge, Division of Pediatric Nephrology  
Affiliation  NRS Medical College and Hospital 
Address  Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata WEST BENGAL 700014

Kolkata
WEST BENGAL
700014
India 
Phone    
Fax    
Email  basuv3000@gmail.com  
 
Source of Monetary or Material Support  
NRS Medical College and Hospital, 138 AJC Bose Road. Kolkata WEST BENGAL 700014  
 
Primary Sponsor  
Name  NRS Medical College and Hospital 
Address  Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata WEST BENGAL 700014 India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shilpita Barua  Room No.16, Div. of Pediatric Nephrology and OPD, Dept. of Pediatrics, NRS Medical College  Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata WEST BENGAL 700014 India
Kolkata
WEST BENGAL 
89577566886

jasminebarua87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NRS Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Nephrotic Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Prednisolone body surface area-based   Prednisolone shall be administered orally as body surface area-based regimen (60 mg/m²/day) orally in two/three divided doses till remission for relapses or till 6 weeks for first episode. Time taken for remission shall be assessed. Then Prednisolone shall be given alternate day dose @ 40mg /m² orally as single dose till 4 weeks for relapses or till 6 weeks for first episode. 
Intervention  Prednisolone body weight-based   Prednisolone shall be administered orally as body weight-based (2mg/kg/day) regimen orally in two/three divided doses till remission for relapses or till 6 weeks for first episode. Time taken for remission shall be assessed. Then Prednisolone shall be given alternate day dose @ 1.5 mg /kg orally as single dose till 4 weeks for relapses or till 6 weeks for first episode.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details 
(1) Age-2 to 12years
(2) Idiopathic Nephrotic Syndrome
(3) Either first episode nephritic syndrome or infrequent relapse nephrotic syndrome
 
 
ExclusionCriteria 
Details  (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
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Relapse free survival over 6 months  3 and 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for initial remission, adverse effects of steroids, cumulative dosage of prednisolone.  3 and 6 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   31/03/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 

 
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