67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details
臨床試験数 : 216 / 薬物数 : 219 - (DrugBank : 50) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 151
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-004400-34-NL (EUCTR) | 12/05/2021 | 04/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 2 | EUCTR2020-004400-34-BE (EUCTR) | 11/05/2021 | 18/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 3 | EUCTR2020-004400-34-PT (EUCTR) | 30/04/2021 | 05/03/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 4 | EUCTR2020-004400-34-DE (EUCTR) | 23/03/2021 | 25/02/2021 | Long-term treatment of autosomal dominant polycystic kidney disease (ADPKD) with venglustat | Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-PKD-EXT | Congenital cystic kidney disease MedDRA version: 20.0;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: GZ/SAR402671 | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 640 | Phase 3 | Portugal;Czechia;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Romania;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of |