Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy
Efficacy and Safety of Rituximab Combined With Cyclosporine for Primary Membranous Nephropathy
High-grade proteinuria is one of the key determinants of adverse renal prognosis in patients with primary membranous nephropathy (PMN).The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.
調査の概要
詳細な説明
Primary membranous nephropathy (PMN) is one of the most common causes of nephrotic syndrome among Chinese adults. For patients with high-grade proteinuria , immunosuppressive therapy is needed. B cell-depleting agent Rituximab is a recommended treatment Regimen in maintaining remission but the response to Rituximab is relatively slow. Calcineurin inhibitors lead to earlier reductions in proteinuria but presenting higher relapse rates in the long follow-up period.Combination therapy may provide both earlier proteinuria remission and durable effect. This is a multi-center, randomized, open-label study conducted in adult patients with biopsy-proven PMN. The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前:Fang Wang, Doctor
- 電話番号:01083572388
- メール:wangfang@bjmu.edu.cn
研究場所
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-
-
Beijing、中国
- 募集
- Peking University First Hospital
-
コンタクト:
- Fang Wang
- 電話番号:86-10-83572388
- メール:wangfang@bjmu.edu.cn
-
-
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 18-80 years.
- Primary membranous nephropathy confirmed by renal biopsy.
- 24-hour urinary protein quantification > 5.0 g/24h and serum albumin < 30 g/L after at least 3 months of treatment with RAAS blockers.
- eGFR ≥ 40 mL/min/1.73 m².
- Well-controlled blood pressure (≤140/90 mmHg) in the recent 3 months.
- Signed informed consent form.
Exclusion Criteria:
- Secondary causes of membranous nephropathy, such as that secondary to systemic lupus erythematosus, malignant tumors, hepatitis B virus infection, heavy metal poisoning;
- Coexistence of other types of kidney diseases;
- Use of rituximab within the past 12 months;
- Use of corticosteroids, cyclophosphamide, cyclosporine, mycophenolate mofetil, or leflunomide within the past 3 months;
- Active infection: active tuberculosis, HBsAg positivity or HBV-DNA indicating viral replication, positive HCV antibody, HIV infection;
- New-onset cardiovascular or cerebrovascular diseases within the past 3
- Severe liver disease: AST and ALT > 3 times range upper limit ;
- Uncontrolled severe hypertension;
- Newly diagnosed or recurrent malignant tumors within the past 5 years;
- Coexistent autoimmune diseases;
- Pregnancy, lactation, or recent plans for pregnancy;
- Life expectancy less than 12 months;
- Participation in other clinical trials within the past 3 months;
- Unwillingness to sign the informed consent form;
- Any other condition deemed unsuitable for the study by the investigator.
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:なし(オープンラベル)
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:combination therapy
Rituximab combined with cyclosporine |
The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml.Oral cyclosporine will be started at 3 mg/kg/day and continued for 6 months, followed by a 2-month tapering period. |
|
アクティブコンパレータ:monotherapy
Rituximab |
The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml. |
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 |
|---|---|---|
|
Remission Status
時間枠:At 3 months after randomization
|
the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization |
At 3 months after randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Remission at 6 months and 12 months
時間枠:From enrollment to the end of follow-up at 12 months
|
The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment. |
From enrollment to the end of follow-up at 12 months
|
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
追加の関連 MeSH 用語
その他の研究ID番号
- Ricyclo-pMN
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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