China Glomerulonephritis Kidney Transplant Recipient Cohort: A Prospective Multicenter Observational Study
This is a prospective observational study aimed at establishing a prospective observational cohort of patients with a confirmed diagnosis of glomerulonephritis (GN) before kidney transplantation in China. Information will be collected on the epidemiology of GN recurrence after kidney transplantation, as well as the outcomes and treatment of the primary disease following kidney transplantation, to provide evidence for subsequent clinical studies, drug development, and translational research.
Approximately 300 patients with a confirmed diagnosis of GN before transplantation will be prospectively enrolled. Clinical data will be collected during screening, kidney transplantation, and a 3-year post-transplant follow-up. The frequency of follow-up visits is every 3 months in the 1st year after transplantation, and every 6 months during the 2nd to 3rd years, with a total of 8 follow-up visits. The study will be conducted at 10 sites across China.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosed with primary GN based on clinical guidelines and/or expert consensus
- Successfully matching completed and confirmed to be scheduled for kidney transplantation.
Exclusion Criteria:
- History of organ transplantation or planned multiple organ transplantation.
- Complicated with malignancy.
- Failure to undergo kidney transplantation for any reason.
- Unable to provide written informed consent form (ICF).
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
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 |
|---|---|---|
|
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
時間枠：3-year follow-up
|
Incidence of GN recurrence after kidney transplantation
|
3-year follow-up
|
|
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
時間枠：3-year follow-up
|
Time to GN recurrence after kidney transplantation (months)
|
3-year follow-up
|
|
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
時間枠：3-year follow-up
|
Factors associated with GN recurrence after kidney transplantation
|
3-year follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To assess other clinical events after kidney transplantation and their associated factors
時間枠：3-year follow-up
|
incidence and time to rejection
|
3-year follow-up
|
|
To assess other clinical events after kidney transplantation and their associated factors
時間枠：3-year follow-up
|
incidence and time to renal allograft loss
|
3-year follow-up
|
|
To assess other clinical events after kidney transplantation and their associated factors
時間枠：3-year follow-up
|
incidence and time to death
|
3-year follow-up
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
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
- D9030R00002
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
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共有時間枠
IPD 共有アクセス基準
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。