DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
51	全身性強皮症	2

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	NCT02047708 (ClinicalTrials.gov)	October 2014	22/1/2014	Zibotentan Better Renal Scleroderma Outcome Study	A Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to Scleroderma	Scleroderma;Scleroderma Renal Crisis;Chronic Kidney Disease	Drug: Zibotentan	University College, London	Medical Research Council	Completed	18 Years	N/A	All	27	Phase 2	United Kingdom
2	EUCTR2013-003200-39-GB (EUCTR)	01/04/2014	04/04/2014	Investigation of Zibotentan for kidney disease in scleroderma	A phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA)	Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease). MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857 MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		University College London	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 2	United Kingdom

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

NCT02047708
(ClinicalTrials.gov)

October 2014

22/1/2014

Zibotentan Better Renal Scleroderma Outcome Study

A Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to Scleroderma

Scleroderma;Scleroderma Renal Crisis;Chronic Kidney Disease

Drug: Zibotentan

University College, London

Medical Research Council

Completed

18 Years

N/A

All

Phase 2

United Kingdom

EUCTR2013-003200-39-GB
(EUCTR)

01/04/2014

04/04/2014

Investigation of Zibotentan for kidney disease in scleroderma

A phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA)

Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease).
MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857
MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

University College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom