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 | EUCTR2021-003062-12-SK (EUCTR) | 11/03/2022 | 16/11/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Portugal;Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 2 | NCT05208866 (ClinicalTrials.gov) | February 10, 2022 | 7/1/2022 | Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303 | PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT Study | Polycystic Kidney Disease, Adult | Drug: Lixivaptan | Palladio Biosciences | NULL | Enrolling by invitation | 18 Years | N/A | All | 12 | Phase 3 | United States |
| 3 | EUCTR2021-003062-12-BG (EUCTR) | 09/02/2022 | 06/12/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Israel;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 4 | EUCTR2021-003062-12-ES (EUCTR) | 21/01/2022 | 20/10/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 5 | EUCTR2021-003062-12-IT (EUCTR) | 20/01/2022 | 18/10/2021 | A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: [0C23] INN or Proposed INN: Lixivaptan | Palladio Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 6 | EUCTR2021-003062-12-HU (EUCTR) | 03/01/2022 | 05/11/2021 | A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment. | A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study. - ACTION | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Lixivaptan Product Code: 0C23 INN or Proposed INN: Lixivaptan Other descriptive name: Lixivaptan | Palladio Biosciences Inc. | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia | ||
| 7 | NCT04064346 (ClinicalTrials.gov) | October 28, 2021 | 19/8/2019 | Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease | A 2-Year, Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase | Polycystic Kidney Disease, Adult | Drug: Lixivaptan;Drug: Placebo | Palladio Biosciences | NULL | Recruiting | 18 Years | 60 Years | All | 1200 | Phase 3 | United States;Argentina;Australia;Canada;Chile;Hungary;Israel;Romania;Spain |
| 8 | NCT04152837 (ClinicalTrials.gov) | September 2, 2020 | 31/10/2019 | Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease | An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study | Polycystic Kidney Disease, Adult | Drug: Lixivaptan | Palladio Biosciences | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 3 | United States |
| 9 | NCT03717181 (ClinicalTrials.gov) | February 19, 2019 | 22/10/2018 | Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease | Expanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease | Polycystic Kidney | Drug: Lixivaptan | Palladio Biosciences | NULL | No longer available | 15 Years | 60 Years | All | United States | ||
| 10 | NCT03487913 (ClinicalTrials.gov) | September 14, 2018 | 16/3/2018 | The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | A Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Lixivaptan | Palladio Biosciences | NULL | Completed | 18 Years | 65 Years | All | 31 | Phase 2 | United States |