NEFECON ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 66 | IgA腎症 | 29 |
66. IgA腎症
臨床試験数 : 255 / 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
| 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 | EUCTR2020-003308-14-FI (EUCTR) | 22/02/2021 | 27/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 2 | EUCTR2020-003308-14-GR (EUCTR) | 03/12/2020 | 26/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 3 | EUCTR2020-003308-14-PL (EUCTR) | 24/11/2020 | 01/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 4 | NCT04541043 (ClinicalTrials.gov) | November 14, 2020 | 1/9/2020 | Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE) | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA Nephropathy | Drug: Nefecon | Calliditas Therapeutics AB | NULL | Recruiting | 18 Years | N/A | All | 250 | Phase 3 | Sweden |
| 5 | EUCTR2020-003308-14-FR (EUCTR) | 13/11/2020 | 13/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of | ||
| 6 | EUCTR2020-003308-14-GB (EUCTR) | 12/11/2020 | 21/10/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 7 | EUCTR2020-003308-14-IT (EUCTR) | 12/11/2020 | 24/05/2021 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 - - | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: [Nefecon] INN or Proposed INN: BUDESONIDE | CALLIDITAS THERAPEUTICS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of | ||
| 8 | EUCTR2020-003308-14-SE (EUCTR) | 21/10/2020 | 18/09/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Korea, Republic of;Sweden;Germany;Australia;Belgium;Poland;Argentina;Canada;Czech Republic;France;Italy;United Kingdom;Turkey;Spain;Finland;Greece;Taiwan;Belarus;United States | ||
| 9 | EUCTR2020-003308-14-CZ (EUCTR) | 21/10/2020 | 16/09/2020 | Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301 | An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of | ||
| 10 | EUCTR2017-004902-16-IT (EUCTR) | 16/11/2018 | 20/01/2021 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primar | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: [Nefecon] INN or Proposed INN: BUDESONIDE | CALLIDITAS THERAPEUTICS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 11 | NCT03643965 (ClinicalTrials.gov) | September 5, 2018 | 8/8/2018 | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) | Primary IgA Nephropathy | Drug: Nefecon;Drug: Placebo oral capsule | Calliditas Therapeutics AB | NULL | Active, not recruiting | 18 Years | N/A | All | 365 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Canada;Czechia;Finland;France;Germany;Greece;Italy;Korea, Republic of;Poland;Spain;Sweden;Taiwan;Turkey;United Kingdom |
| 12 | EUCTR2017-004902-16-PL (EUCTR) | 27/08/2018 | 18/07/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - NefIgArd | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada | ||
| 13 | EUCTR2017-004902-16-FI (EUCTR) | 18/07/2018 | 02/03/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 14 | EUCTR2017-004902-16-BE (EUCTR) | 18/06/2018 | 21/02/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 15 | EUCTR2017-004902-16-CZ (EUCTR) | 04/06/2018 | 12/02/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 16 | EUCTR2017-004902-16-GB (EUCTR) | 29/05/2018 | 22/06/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 17 | EUCTR2017-004902-16-ES (EUCTR) | 09/04/2018 | 02/03/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden | ||
| 18 | EUCTR2017-004902-16-SE (EUCTR) | 28/03/2018 | 13/02/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 19 | EUCTR2012-001923-11-ES (EUCTR) | 09/01/2013 | 29/11/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 14.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 20 | EUCTR2012-001923-11-NL (EUCTR) | 18/12/2012 | 19/10/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 16.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 21 | EUCTR2012-001923-11-DE (EUCTR) | 10/12/2012 | 22/08/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 22 | NCT01738035 (ClinicalTrials.gov) | December 2012 | 25/7/2012 | The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease | A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease | Primary IgA Nephropathy | Drug: NEFECON;Other: Placebo | Pharmalink AB | NULL | Completed | 18 Years | N/A | Both | 150 | Phase 2 | Belgium;Czech Republic;Denmark;Finland;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 23 | EUCTR2012-001923-11-SE (EUCTR) | 21/11/2012 | 03/09/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 24 | EUCTR2012-001923-11-BE (EUCTR) | 19/11/2012 | 22/08/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 25 | EUCTR2012-001923-11-GB (EUCTR) | 06/11/2012 | 28/09/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 26 | EUCTR2012-001923-11-DK (EUCTR) | 05/11/2012 | 14/09/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 27 | EUCTR2012-001923-11-CZ (EUCTR) | 24/10/2012 | 16/08/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 28 | EUCTR2012-001923-11-FI (EUCTR) | 17/10/2012 | 15/08/2012 | A study to assess if two different doses of Nefecon (budesonide) compared to placebo are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 29 | EUCTR2012-001923-11-IT (EUCTR) | 27/09/2012 | 24/09/2012 | A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease - NEFIGAN Trial | Primary IgA nephropathy at risk of developing end stage renal disease MedDRA version: 15.0;Level: LLT;Classification code 10037034;Term: Proteinuria present;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: A07EA06 INN or Proposed INN: BUDESONIDE | CROWN OY | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden |