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Clinical Trial Details

Trial ID: L0416
Source ID: NCT01738035
Associated Drug: Nefecon
Title: The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease
Acronym: NEFIGAN
Status: COMPLETED
Study Results: NO
Results:
Conditions: Primary IgA Nephropathy
Interventions: DRUG: NEFECON|OTHER: Placebo
Outcome Measures: Primary: Change from baseline in urine protein creatinine ratio, 9 months | Secondary: Change from baseline in urine albumin creatinine ratio, 9 months|Change from baseline in 24 hour albuminuria, 9 months|Change from baseline in estimated GFR, 9 months | Other: Change from baseline in urine protein creatinine ratio, 3-12 months|Change in urine albumin creatinine ratio, 3-12 months|Change from baseline in 24 hour albuminuria, 3-12 months|Change from baseline in estimated GFR, 3-12 months
Sponsor/Collaborators: Sponsor: Calliditas Therapeutics AB
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-12
Completion Date: 2015-09
Results First Posted:
Last Update Posted: 2015-09-24
Locations: University Hospital of Antwerp, Antwerp, Belgium|Imelda Hospital, Bonheiden, Belgium|Ghent University Hospital, Ghent, Belgium|University Hospitals Leuven, Leuven, Belgium|Heilig Hartziekenhuis Roeselare-Menen, Roeselare, Belgium|University Hospital, Olomouc, Czech Republic|Charles University & General University Hospital, Prague, Czech Republic|Institut klinické a experimentální medicíny, Prague, Czech Republic|Rigshospitalet, Copenhagen, Denmark|Herlev Hospital, Herlev, Denmark|Odense University Hospital, Odense, Denmark|Helsinki University Central Hospital, Helsinki, Finland|Tampere University Hospital, Tampere, Finland|Turku University Central Hospital, Turku, Finland|RWTH Aachen, Aachen, Germany|Klinikum Augsburg, Augsburg, Germany|Charité Hospital, Berlin, Germany|Charité-Virchow Clinic, Berlin, Germany|Vivantes Klinikum im Friedrichshain, Berlin, Germany|Klinikum-Bremen-Mitte, Bremen, Germany|University Hospital Carl Gustav Carus, Dresden, Germany|Studienzentrum Karlstrasse, Düsseldorf, Germany|Universitätsklinikum Erlangen, Erlangen, Germany|Universitätsmedizin Göttingen, Göttingen, Germany|University Hospital, Heidelberg, Germany|University of Jena, Jena, Germany|Universitätsklinikum Magdeburg, Magdeburg, Germany|Universität München, Munich, Germany|Universitätsklinikum Münster, Münster, Germany|Universitätsklinikum Regensburg, Regensburg, Germany|Deutsche Klinik für Diagnostik, Wiesbaden, Germany|Würzburg University Hospital, Würzburg, Germany|Policlinico di Bari, Bari, Italy|Azienda Ospedaliera G. Brotzu, Cagliari, Italy|Ospedale A Manzoni, Lecco, Italy|Bassini Hospital, Milano, Italy|Ospedale S. G. Bosco, Torino, Italy|Belcolle Hospital, Viterbo, Italy|University Medical Center, Leiden, Netherlands|Fundación Puigver, Barcellona, Spain|Hospital Universitario Vall d'Hebron, Barcellona, Spain|12 de Octubre Hospital, Madrid, Spain|Fundación Jimenez Diaz Hospital, Madrid, Spain|Hospital Universitario Gregorio Marañon, Madrid, Spain|Central sjukhuset, Karlstad, Sweden|Karlstad Central Hospital, Karlstad, Sweden|University Hospital, Linköping, Sweden|Danderyds Hospital, Stockholm, Sweden|Karolinska University Hospital, Stockholm, Sweden|Uppsala University Hospital, Uppsala, Sweden|Belfast City Hospital, Belfast, United Kingdom|Ulster Hospital, Belfast, United Kingdom|Royal Derby Hospital, Derby, United Kingdom|Edinburgh Royal Infirmary, Edinburgh, United Kingdom|Western Infirmary, Glasgow, United Kingdom|The Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom|Leicester General Hospital, Leicester, United Kingdom|James Cook University Hospital, Middlesbrough, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01738035

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress