常染色体優性多発性嚢胞腎における二価イオンに対するSGLT2阻害剤の短期効果 (SIDIA)
This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.
調査の概要
詳細な説明
This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.
At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.
At week 3 & 7, a phone consultation will assess safety.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Canton of Zurich
-
Zurich、Canton of Zurich、スイス、8091
- University Hospital Zurich, Division of Nephrology
-
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Kanton Graubünden
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Chur、Kanton Graubünden、スイス、7000
- Cantonal Hospital Graubuenden
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
- Informed consent as documented by signature
Exclusion Criteria:
- - renal replacement therapy or kidney allograft recipient
- chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
- patients younger 18 years of age
- Diabetes mellitus type 1
- recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
- Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)
- Patients not able or not willing to stop the following medications during the study period of participation in the trial:
- Thiazide diuretics
- Carbonic anhydrase inhibitors
- Sodium bicarbonate
- 1, 25 (OH) vitamin D (calcitriol)
- Bisphosphonate, denosumab, teriparatide
- Pregnant or lactating women
- Known allergy to study drug
- Inability to understand and follow the protocol
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
Empagliflozin 10mg |
Empagliflozin 10mg |
|
プラセボコンパレーター：Control
Placebo |
Placebo capsule |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
24-hour Urinary Phosphate
時間枠：End of each 14 day treatment period
|
Total phosphate excretion measured in a 24-hour urine collection at the end of each treatment period. |
End of each 14 day treatment period
|
|
24-hour Urinary Calcium Excretion
時間枠：End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on 24-hour urinary calcium excretion after each 14-day treatment period in a randomized crossover trial. |
End of each 14-day treatment period
|
|
24-hour Urinary Magnesium Excretion
時間枠：End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on 24-hour urinary magnesium excretion after each 14-day treatment period in a randomized crossover trial. |
End of each 14-day treatment period
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Phosphate
時間枠：End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on serum phosphate after each 14-day treatment period. |
End of each 14-day treatment period
|
|
Serum Calcium
時間枠：End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on serum calcium after each 14-day treatment period. |
End of each 14-day treatment period
|
|
Serum Magnesium
時間枠：End of each 14-day treatment period
|
Effect of empagliflozin compared with placebo on serum magnesium after each 14-day treatment period. |
End of each 14-day treatment period
|
|
24-hour Urine Volume
時間枠：End of each 14-day treatment period
|
Total urine volume collected over 24 hours at the end of each treatment period. |
End of each 14-day treatment period
|
協力者と研究者
捜査官
- 主任研究者：Thomas Fehr, MD、Cantonal Hospital Graubuenden
- 主任研究者：Patrick Hofmann, MD、Cantonal Hospital Graubuenden
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024-00070
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The local ethics committee approval does not include individual participant data sharing.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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