R3R01 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
218アルポート症候群2
222一次性ネフローゼ症候群2

218. アルポート症候群


臨床試験数 : 30 薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05267262
(ClinicalTrials.gov)
June 15, 202223/2/2022Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGCAlport Syndrome;Focal Segmental GlomerulosclerosisDrug: R3R01River 3 Renal Corp.NULLRecruiting12 YearsN/AAll50Phase 2United States;Belgium;France;Germany;Netherlands;United Kingdom
2EUCTR2021-004192-13-BE
(EUCTR)
19/05/2022R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis - R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis Alport Syndrome (AS) and Primary Steroid-Resistent FocalSegmental Glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: R3R01
INN or Proposed INN: not available
Other descriptive name: R3R01
River 3 Renal, CorporationNULLNAFemale: yes
Male: yes
50Phase 2France;United States;Belgium;Germany;Netherlands;United Kingdom

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05267262
(ClinicalTrials.gov)
June 15, 202223/2/2022Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGCAlport Syndrome;Focal Segmental GlomerulosclerosisDrug: R3R01River 3 Renal Corp.NULLRecruiting12 YearsN/AAll50Phase 2United States;Belgium;France;Germany;Netherlands;United Kingdom
2EUCTR2021-004192-13-BE
(EUCTR)
19/05/2022R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis - R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis Alport Syndrome (AS) and Primary Steroid-Resistent FocalSegmental Glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: R3R01
INN or Proposed INN: not available
Other descriptive name: R3R01
River 3 Renal, CorporationNULLNAFemale: yes
Male: yes
50Phase 2France;United States;Belgium;Germany;Netherlands;United Kingdom