66. IgA腎症 IgA nephropathy Clinical trials / Disease details


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140

  
27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003308-14-FI
(EUCTR)
22/02/202127/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Belarus;United States;Czechia;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Korea, Republic of;Sweden
2EUCTR2020-003308-14-GR
(EUCTR)
03/12/202026/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
3EUCTR2020-003308-14-PL
(EUCTR)
24/11/202001/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
4EUCTR2020-003308-14-FR
(EUCTR)
13/11/202013/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
5EUCTR2020-003308-14-GB
(EUCTR)
12/11/202021/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
6EUCTR2020-003308-14-IT
(EUCTR)
12/11/202024/05/2021Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
7EUCTR2020-003308-14-SE
(EUCTR)
21/10/202018/09/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
8EUCTR2020-003308-14-CZ
(EUCTR)
21/10/202016/09/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
9EUCTR2017-004902-16-IT
(EUCTR)
16/11/201820/01/2021A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
10EUCTR2017-004902-16-PL
(EUCTR)
27/08/201818/07/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Argentina;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
11EUCTR2017-004902-16-FI
(EUCTR)
18/07/201802/03/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;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
12EUCTR2017-004902-16-BE
(EUCTR)
18/06/201821/02/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;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
13EUCTR2017-004902-16-CZ
(EUCTR)
04/06/201812/02/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;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
14EUCTR2017-004902-16-GB
(EUCTR)
29/05/201822/06/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
15EUCTR2017-004902-16-ES
(EUCTR)
09/04/201802/03/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden
16EUCTR2017-004902-16-SE
(EUCTR)
28/03/201813/02/2018A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;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
17EUCTR2012-001923-11-ES
(EUCTR)
09/01/201329/11/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
18EUCTR2012-001923-11-NL
(EUCTR)
18/12/201219/10/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
19EUCTR2012-001923-11-DE
(EUCTR)
10/12/201222/08/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Sweden;Netherlands;Belgium;Finland;Denmark;Italy;United Kingdom;Germany;Spain
20EUCTR2012-001923-11-SE
(EUCTR)
21/11/201203/09/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
21EUCTR2012-001923-11-BE
(EUCTR)
19/11/201222/08/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
22EUCTR2012-001923-11-GB
(EUCTR)
06/11/201228/09/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
23EUCTR2012-001923-11-DK
(EUCTR)
05/11/201214/09/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
24EUCTR2012-001923-11-CZ
(EUCTR)
24/10/201216/08/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
25EUCTR2012-001923-11-FI
(EUCTR)
17/10/201215/08/2012A 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 diseaseA 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 ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
26EUCTR2012-001923-11-IT
(EUCTR)
27/09/201224/09/2012A 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 diseaseA 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 OYNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
27NCT00767221
(ClinicalTrials.gov)
October 20055/10/2008Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative StudyOral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative StudyIGA NephropathyDrug: BudesonidePharmalink ABArchimedes Development LtdCompleted18 YearsN/ABoth20Phase 2Sweden