Back
| autoid | 26 |
| crg_id | CRG100500015 |
| titleoftrial | Treatment of idiopathic membranous glomerulonephritis with FK-506 (Tacrolimus): A prospective, randomized, open and controlled study |
| acronymnoftrial | Tacrolimus in membranous glomerulonephritis |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Praga |
| leadgivennames | Manuel |
| leadposition | Head of Department |
| leaddepartment | Nephrology |
| leadorganisation | Department of Nephrology, Hospital 12 de Octubre |
| leadaddress | Dr. Praga. Servicio de Nefrologia. Hospital 12 de Octubre. Avda de Cordoba s/n. 28041 Madrid, Spain |
| leademail | mpragat@senefro.org |
| leadphone | +34 91 3908383 |
| leadfax | +34 91 3908393 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | |
| otherfunding | |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | |
| actualstart | 02/2003 |
| proposedcompletiondate | |
| actualcompletiondate | 12/2005 |
| multi_center_study | yes |
| numberofcentres | 13 |
| multi_national_study | no |
| countrycentres | Spain |
| researchquestion | To study the number of patients with nephrotic syndrome by membranous nephropathy treated with tacrolimus that achieve complete/partial remission or develop renal insufficiency in comparison with a control group receiving standard nonimmunosupressive therapy |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Nephrotic syndrome |
| intervention1 | FK-506 (Tacrolimus) |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18-75 years |
| totalrecruitment | 50 |
| inclusion | Biopsy-proven membranous nephropathy, with nephrotic proteinuria for at least 9 months and non response to ACEI/ARB treatment |
| exclusion | -Non-nephrotic proteinuria
-Estimated Ccr<50 ml/min -Diabetes and systemic diseases |
| primaryoutcomes | -Complete or partial remission of nephrotic syndrome
-Development of renal insufficiency |
| secondaryoutcomes | -Proteinuria
-Serum creatinine/creatinine clearance -Safety and tolerability of tacrolimus in nephrotic syndrome by membranos nephropathy |
| reference | 1. Praga M. Barrio V. Juarez GF. Luno J. Grupo Espanol de Estudio de la Nefropatia Membranosa. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.[see comment]. Kidney International. 71(9):924-30, 2007 May. [added by Gail Higgins 20/08/2007] |