Back
| autoid | 109 |
| crg_id | CRG030600042 |
| titleoftrial | Randomized Controlled Trial on Efficacy and Safety of Cyclosporin versus Tacrolimus in Children with Steroid Resistant Nephrotic Syndrome |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Bagga |
| leadgivennames | Arvind |
| leadposition | Professor |
| leaddepartment | Division of Pediatric Nephrology, Pediatrics |
| leadorganisation | All India Institute of Medical Sciences |
| leadaddress | A.I.I.M.S., Ansari Nagar, New Delhi, India 110029 |
| leademail | arvindbagga@hotmail.com |
| leadphone | +91 11 26593472 |
| leadfax | +91 11 26588641 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | other |
| otherfunding | No direct funding but study medication supplied to patients by the drug company. |
| fundingnameofsponsors | Panacea Biotec Limited |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | |
| actualstart | |
| proposedcompletiondate | |
| actualcompletiondate | Sep 2005 |
| multi_center_study | no |
| numberofcentres | 1 |
| multi_national_study | no |
| countrycentres | India |
| researchquestion | To compare the efficacy of 12 month’s therapy with tacrolimus versus CyA in inducing remission in patients with initial or late SRNS.
|
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | |
| healthcarecondition | Steroid Resistant Nephrotic Syndrome |
| intervention1 | Therapy with either cyclosporin or tacrolimus |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | children |
| age | 1-18 years |
| totalrecruitment | 30 |
| inclusion | 1. Patients, between the ages of 1 and 18 years, with idiopathic SRNS and failure to respond to 3 month’s treatment with intravenous pulses of cyclophosphamide or dexamethasone
2. Subjects with renal histology suggestive of minimal change disease; mild to moderate mesangial proliferative GN and focal segmental glomerulosclerosis 3. Subjects whose parents provide informed consent before commencing treatment |
| exclusion | 1. History of having received immunosuppressive medications other than oral corticosteroids e.g., intravenous or oral cyclophosphamide, dexamethasone, azathioprine, MMF in the preceding 4 weeks.
2. Previous therapy with CyA or tacrolimus. 3. Nephrotic syndrome secondary to systemic diseases (SLE, hepatitis B infection, vasculitis, IgA nephropathy, amyloidosis) 4. Renal histology showing severe mesangial proliferative GN (≥6 cells per mesangial area), membranoproliferative GN or membranous nephropathy 5. Serum creatinine >1.5 mg/dL or GFR (Schwartz) <50 ml/min/1.73 m2. |
| primaryoutcomes | |
| secondaryoutcomes | |
| reference | Choudbry S, Bagga A, Menon S, Hari P. Randomized controlled trial (RCT) on efficacy and safety of cyclosporin (CyA) vs tacrolimus (Tac) in steroid resistant nephrotic syndrome (SRNS) [CRG030600042] [abstract no: 182 (OP)] Pediatric Nephrology 2007; 22(9):1480 [updated by GYH 19 Aug 2008] |