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
|
|
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
|
|
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. |