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
67	多発性嚢胞腎	1

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	EUCTR2011-005017-37-NL (EUCTR)	30/05/2012	21/05/2012	To investigate the effect of Lanreotide on renal function decline in ADPKD patients	A randomised, controlled clinical trial assessing the efficacy ofLanreotide to halt disease progression in ADPKD - The DIPAK 1 Study	First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume. MedDRA version: 14.1;Level: LLT;Classification code 10023433;Term: Kidney polycystic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Somatuline Autogel Product Name: Lanreotide Product Code: BIM 23014 INN or Proposed INN: Lanreotide Other descriptive name: LANREOTIDE ACETATE	DIPAK Consortium	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands

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

EUCTR2011-005017-37-NL
(EUCTR)

30/05/2012

21/05/2012

To investigate the effect of Lanreotide on renal function decline in ADPKD patients

A randomised, controlled clinical trial assessing the efficacy ofLanreotide to halt disease progression in ADPKD - The DIPAK 1 Study

First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume.
MedDRA version: 14.1;Level: LLT;Classification code 10023433;Term: Kidney polycystic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Somatuline Autogel
Product Name: Lanreotide
Product Code: BIM 23014
INN or Proposed INN: Lanreotide
Other descriptive name: LANREOTIDE ACETATE

DIPAK Consortium

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands