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 |
Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study
STOPCYST Phase II Safety Study
Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study
STOPCYST Phase II Safety Study
Japan |
Autosomal Dominant Polycystic Kidney Disease (ADPKD), Autosomal Dominant Polycystic Liver Disease (ADPLD).
Gastroenterology | Nephrology | Urology |
Others
NO
To examine safety of sandostatin administration to patients with ADPKD and ADPLD.
Safety
Confirmatory
Pragmatic
Phase II
1) vital signs, 2) adverse events, 3) laboratory data, 4) develpement of cholelithiasis
1) Change of liver and kidney volume measured with MRI (CT). 2) Change of QOL-related questionnaire score.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Sandostatin
20 | years-old | <= |
60 | years-old | >= |
Male and Female
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
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.
4
1st name | |
Middle name | |
Last name | Eiji Higashihara |
Kyorin University
School of Medicine, Dept. of Urology
6-20-2 Shinkawa, Mitaka, Tokyo
0422-47-5511
ehigashi@ks.kyorin-u.ac.jp
1st name | |
Middle name | |
Last name | Eiji Higashihara |
Kyorin University
School of Medicine, Department of Urology
6-20-2 Shinkawa, Mitaka, Tokyo
0422-47-5511
ehigashi@ks.kyorin-u.ac.jp
Department of Urology, School of Medicine, Kyorin University
Department of Urology, School of Medicine, Kyorin University
Kyorin University Hospital
Self funding
NO
2012 | Year | 12 | Month | 15 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 17 | Day |
2012 | Year | 12 | Month | 15 | Day |
2012 | Year | 12 | Month | 31 | Day |
2012 | Year | 12 | Month | 31 | Day |
2013 | Year | 01 | Month | 30 | Day |
2013 | Year | 03 | Month | 30 | Day |
2012 | Year | 10 | Month | 29 | Day |
2014 | Year | 05 | Month | 03 | Day |
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 |