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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009214
Enrollment
4
Registered
2012-12-15
Start date
2012-12-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Sponsors

Department of Urology, School of Medicine, Kyorin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Contacts

Public ContactEiji Higashihara

Kyorin University School of Medicine, Department of Urology

ehigashi@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026