活動性ループス腎炎におけるダパグリフロジン (Dapa-Active LN)
ループス腎炎におけるナトリウム-グルコース共輸送体-2阻害薬
Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease. This pilot and feasibility randomized clinical trial will test the use of dapagliflozin versus placebo in addition to standard of care treatment for patients with early and active lupus nephritis, a group who has not been included in past trials.
調査の概要
詳細な説明
This is a pilot and feasibility randomized, double-blind, placebo-controlled trial involving patients with active lupus nephritis. It will be a concealed allocation, blinded randomized controlled trial of dapagliflozin 10 mg/day or matched placebo in a 2:1 allocation ratio (22 subjects active arm: 11 subjects placebo arm), in addition to standard-of-care treatment, for 12 weeks. After informed consent, 33 eligible subjects will be randomized 2:1 to oral dapagliflozin 10 mg/day or identical oral placebo/day for 12 weeks. Study visits will occur at screening (Visit -1), baseline (Visit 0) and weeks 4 (Visit 1), 8 (Visit 2) and 12 (Visit 3). Observational data including laboratory test results obtained in routine clinical care will be collected through 12 months of follow-up.
The primary outcomes are:
- the overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial;
- feasibility and completeness of data collection procedures;
- changes in urine protein-to-creatinine ratio (UPCR) and precision of these estimates from baseline to week 12 in each group; and
- rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Karen H Costenbader, MD, MPH
- 電話番号：(617) 525-8785
- メール：kcostenbader@bwh.harvard.edu
研究連絡先のバックアップ
- 名前：April M Jorge, MD
- 電話番号：617-643-9624
- メール：amjorge@mgh.harvard.edu
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02115
- 募集
- Brigham and Women's Hospital
-
コンタクト：
- Karen H. Costenbader, MD, MPH
- 電話番号：617-732-6088
- メール：KCostenbader@bwh.harvard.edu
-
Boston、Massachusetts、アメリカ、02114
- 募集
- Massachusetts General Hospital
-
コンタクト：
- April M. Jorge, MD
- 電話番号：617-643-9624
- メール：amjorge@mgh.harvard.edu
-
-
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:
-
• Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN
-
Active (new or relapsing) LN within the prior six months, with at least one of the following:
- Kidney biopsy with activity index >2 and/or
- Active urinary sediment (>5 RBCs, >5 WBCs, or cellular casts)
-
Receiving standard-of-care immunosuppression regimen for active LN, including mycophenolate, cyclophosphamide, belimumab, azathioprine, a calcineurin inhibitor, and/or B cell depleting therapies
-
Recent or ongoing glucocorticoids use for active LN within the past 6 months
-
Receiving standard-of-care antimalarial therapy and RAAS blockade, unless contraindicated
-
Estimated ≥0.5 g/g 24 hr proteinuria or ≥0.3 mg/g 24 hr microalbuminuria at enrollment (on first morning urine)
-
Ability to given informed consent
-
Exclusion Criteria:
-
GFR < 25 ml/min/1.73m2
- Acute kidney injury at study enrollment (>50 percent rise in creatinine within 90 days)
- Type I diabetes, underweight (BMI <18.5), active malignancy, active infection, or recurrent genitourinary infections
- For females: pregnancy, or desiring of pregnancy and not using contraception, or unable to use contraception
- Current use of >1mg/kg/day prednisone equivalent
- Current or prior use of SGLT2 inhibitors or GLP-1 receptor agonists
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：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Dapagliflozin 10 mg daily
Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks |
Pilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN) |
|
プラセボコンパレーター：Matching placebo pill daily
Subjects will receive a matching placebo pill to take daily for 12 weeks |
Matching placebo daily with standard of care |
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 |
|---|---|---|
|
Proportion of eligible enrolled
時間枠：3 years
|
The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial |
3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of data collection
時間枠：3 years
|
We will assess the percent of missing data elements overall at pilot trial completion. |
3 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in urine protein-to-creatinine ratio
時間枠：12 weeks per subject
|
Change in urine protein-to-creatinine ratio (UPCR) from baseline to week 12 in each group |
12 weeks per subject
|
|
Adverse outcomes
時間枠：3 years
|
Rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion |
3 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2025P003238
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
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