| 基本情報/Basic information |
| 一般向け試験名/Public title |
「ソマトスタチン（サンドスタチン）の多発性嚢胞腎・多発性嚢胞肝患者少数例での安全性(有効性)を検討する」第Ⅱ相試験 |
Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study |
| 一般向け試験名略称/Acronym |
多発性嚢胞腎患者に於けるサンドスタチンの安全性試験 |
STOPCYST Phase II Safety Study |
| 科学的試験名/Scientific Title |
「ソマトスタチン（サンドスタチン）の多発性嚢胞腎・多発性嚢胞肝患者少数例での安全性(有効性)を検討する」第Ⅱ相試験 |
Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study |
| 科学的試験名略称/Scientific Title:Acronym |
多発性嚢胞腎患者に於けるサンドスタチンの安全性試験 |
STOPCYST Phase II Safety Study |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
サンドスタチン |
Sandostatin |
| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
1）本試験に同意したADPKD, ADPLD患者。
2）eGFR > 45 ml/min/1.73m2
3）以下の内いずれかを満たす者。
○ 肝臓体積＞3000ml。
○ 総腎臓体積＞1000ml。
○ アンケートで腎臓・肝臓腫大による症状の強い者
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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
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| 除外基準/Key exclusion criteria |
1） 治療に関する注意事項を遵守出来ない患者。
2） 授乳中、妊娠中、研究参加期間中避妊を出来ない女性患者。
3) 未治療または重度の糖尿病がある患者。
4) 本物質、または化学構造が類似する薬物に重度のアレルギー反応がある者。
5） 併存症などのために、評価項目の評価が出来ない者。
6） 症候性胆石症がある患者。
7） 試験期間中に手術を予定している患者。
8） 他の臨床治験に参加している患者。
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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.
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| 目標参加者数/Target sample size |
4 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
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| 組み入れ参加者数/Number of participants that the trial has enrolled |
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| 主な結果/Results |
Background
In autosomal dominant polycystic kidney disease (ADPKD), the total kidney volume (TKV) progressively increases and kidney function decreases. Total liver volume (TLV) also increases in 60 to 80 % patients. It was reported that the somatostatin analogue octreotide longacting release (LAR) treatment retarded TKV and TLV enlargement. In this preliminary study, safety and efficacy of octreotide-LAR were evaluated in small cases.
Methods
Patients with ADPKD, estimated glomerular filtration rate (eGFR) higher than 45 ml/min/1.73m2 and TKV and TLV larger than 1000ml and 3000ml respectively were enrolled. Two 20 mg octreotide-LAR intramuscular injection repeated every four weeks for 24 weeks. Laboratory and clinical assessments were repeated every four weeks and TKV and TLV were measured before and after the study.
Results
Four patients participated study. Blood chemistries including fasting blood sugar and blood cell counts were stable during octreotide-LAR treatment. ALT decreased significantly after treatment. The mean of TKV and TLV decreased from 2007 to 1903 ml and from 9197 to 8866 ml respectively but changes were not significant. eGFR did not change significantly. Adverse events included loose stool in two patients, granuloma at the injection site and abdominal pain each in one patient encountered mostly during the early times were self-resolving nature.
Conclusion
This small experience confirmed that administration of octreotide-LAR seems safe as were reported by others.
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| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
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| 参加者の流れ/Participant flow |
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| 有害事象/Adverse events |
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| 評価項目/Outcome measures |
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| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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