UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009214
Receipt number R000010817
Scientific Title Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study
Date of disclosure of the study information 2012/12/15
Last modified on 2014/05/03 15:27:19

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Basic information

Public title

Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study

Acronym

STOPCYST Phase II Safety Study

Scientific Title

Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study

Scientific Title:Acronym

STOPCYST Phase II Safety Study

Region

Japan


Condition

Condition

Autosomal Dominant Polycystic Kidney Disease (ADPKD), Autosomal Dominant Polycystic Liver Disease (ADPLD).

Classification by specialty

Gastroenterology Nephrology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine safety of sandostatin administration to patients with ADPKD and ADPLD.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

1) vital signs, 2) adverse events, 3) laboratory data, 4) develpement of cholelithiasis

Key secondary outcomes

1) Change of liver and kidney volume measured with MRI (CT). 2) Change of QOL-related questionnaire score.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sandostatin

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patient with ADPKD and ADPLD, who consent to the protocol.
2. eGFR >45 ml/min/1.73m2
3. Patient who satisfy one or more following conditions
Liver volume >3000 ml
Total kidney volume >1000 ml
Two symptom score >3 or one symptom score >4


Key exclusion criteria

1) Subjects who are unlikely to adequately comply with trial's procedure.
2) Pregnant or lactating woman.
3) Subjects with uncontrolled or severe diabetes.
4) Subjects with allergy to octreotide or chemicals with similar structure to octreotide.
5) Subjects with comorbidity which interfare clinical evaluation.
6) Subjects with gall bladder stone.
7) Subjects who have scheduled surgery during trial.
8) Subjects taking other experimental therapies.

Target sample size

4


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Higashihara

Organization

Kyorin University

Division name

School of Medicine, Dept. of Urology

Zip code


Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

0422-47-5511

Email

ehigashi@ks.kyorin-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Higashihara

Organization

Kyorin University

Division name

School of Medicine, Department of Urology

Zip code


Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

0422-47-5511

Homepage URL


Email

ehigashi@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Department of Urology, School of Medicine, Kyorin University

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, School of Medicine, Kyorin University
Kyorin University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 10 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 15 Day

Last follow-up date

2012 Year 12 Month 31 Day

Date of closure to data entry

2012 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 01 Month 30 Day

Date analysis concluded

2013 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 29 Day

Last modified on

2014 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010817


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name