糸球体腎炎を治療するための KP104 の有効性、安全性、薬物動態、および薬力学
IgA腎症（IgAN）および補体3糸球体症（C3G）の被験者におけるKP104の有効性、安全性、薬物動態、および薬力学を評価する非盲検第2相試験
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort. Approximately 42 participants with IgAN will be enrolled in 2 stages: Stage 1 will be used to collect safety, immunogenicity, PK, and PD data to select the optimal biologic dose (OBD) of KP104 for IgAN, as well as to preliminarily explore the effect of KP104 on C3G. Stage 2 will be used to collect safety, immunogenicity, PK, PD, and efficacy data at the OBD dose of KP104 for IgAN and C3G. As soon as the OBD for IgAN is determined, eligible participants with C3G will be enrolled and dosed at the OBD for IgAN for a minimum of 48 weeks for weekly maintenance dosing and a minimum of 47 weeks for biweekly maintenance dosing. Approximately 10 participants with C3G will be enrolled.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Study Director
- 電話番号：650-549-1400
- メール：privacy@kirapharma.com
研究場所
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-
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Beijing、中国
- 募集
- Peking University First Hospital
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コンタクト：
- Investigative Site #1
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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:
- Weight of >35 kilograms (kg) at Screening
- Body mass index (BMI) of <35 kilograms per square meter (kg/m^2)
- UPCR >1.0 grams per gram (g/g) by 24-hour urine collection at Screening
- Documented diagnosis and clinical status of IgAN or C3G as follows:
IgAN:
- Diagnosis of IgAN verified by biopsy taken within the past 3 years prior to enrolment.
- On stable regimen of angiotensin converting enzyme or angiotensin blocking agents for 12 weeks and/or sodium-glucose cotransporter-2 (SGLT2) inhibitors for 6 weeks at Screening
C3G:
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Diagnosis of C3G verified by biopsy taken within the past 3 years prior to enrolment.
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On stable regimen of angiotensin converting enzyme or angiotensin blocking agents for 12 weeks and/or SGLT2 inhibitors for 6 weeks at Screening
- Females of childbearing potential and males must practice effective contraception from Screening until 28 days after the end of study (EOS) visit.
- Females of childbearing potential must have a negative pregnancy test at Screening and within 1 day prior to dosing of study drug
Exclusion Criteria:
- Any clinically significant, poorly controlled underlying illness other than IgAN or C3G, as determined by the investigator
- Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibiotics, antivirals, or antifungals
- History of infections with encapsulated organisms
- History of untreated tuberculosis
- Positive serology for hepatitis C virus (HCV) ribonucleic acid (RNA) or human immunodeficiency virus (HIV) at Screening
- History of bone marrow or stem cell transplantation
- Absolute neutrophil count (ANC) <500 cells per microliter (cells/μL)
- eGFR <30 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Presence of crescent formation in >50 percent (%) of glomeruli assessed on renal biopsy
- Nephrotic syndrome defined as presence of substantial proteinuria (> 3.5 g/24 hours), hypoalbuminemia (< 30 grams per liter [g/L]), and edema/hyperlipidemia. Nephrotic range proteinuria alone is acceptable.
- Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m^2 within 24 weeks prior to the Screening Visit
- Receiving renal replacement therapy or anticipated to require renal replacement therapy during the duration of the study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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：順次割り当て
- 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 |
|---|---|
|
実験的：IgAN Cohort Stage 1 Dose 1
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 1. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period. |
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
|
実験的：C3G Cohort Stage 1 Dose 1
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 1. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period. |
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
|
実験的：IgAN Cohort Stage 1 Dose 2
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 2. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period. |
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
|
実験的：C3G Cohort Stage 1 Dose 2
Participants will be randomized to receive weekly or biweekly maintenance doses of KP104 at Dose 2. Participants in Stage 1 will also have the opportunity to be switched to the OBD if they are still in the treatment period. |
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
|
実験的：IgAN Cohort Stage 2
Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD. |
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
|
実験的：C3G Cohort Stage 2
Participants will receive weekly or biweekly maintenance doses of KP104 at the OBD. |
Participants will receive loading and/or weekly maintenance subcutaneous (SC) doses of KP104. |
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 |
|---|---|---|
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Percent change from Baseline in 24-hour urinary protein creatinine ratio (UPCR) at Week 24 (C3G) for participants in Stage 2
時間枠：Baseline and at Week 24
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The UPCR will be calculated as percent change in protein (Pr)/ Creatinine (Cr). |
Baseline and at Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ステージ 2 の参加者の 24 週目 (C3G) における推定糸球体濾過率 (eGFR) のベースラインからの変化
時間枠：ベースラインと24週目
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ベースラインと24週目
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|
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Number of participants reporting Treatment-Emergent Adverse Events (TEAEs)
時間枠：Up to 56 Weeks
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An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. A TEAE is defined as any AE that started or worsened in severity on or after the first dose of study treatment. |
Up to 56 Weeks
|
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Number of participants reporting Treatment-Emergent Serious Adverse Events (TESAEs)
時間枠：Up to 56 Weeks
|
A TESAE is defined as a serious AE (SAE) that started or worsened in severity on or after the first dose of study treatment. |
Up to 56 Weeks
|
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Number of participants reporting AEs of Special Interest (AESIs)
時間枠：Up to 56 Weeks
|
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease or any worsening of a pre-existing condition temporally associated with the use of a study drug, whether or not related to study drug. Number of participants with AESIs including infections and local or systemic administration reactions will be assessed. |
Up to 56 Weeks
|
|
Maximum concentration (Cmax) of KP104
時間枠：At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395
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Blood samples will collected at indicated timepoints to assess Cmax. |
At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395
|
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Trough concentration (Ctrough) of KP104 at steady state
時間枠：At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395
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Blood samples will collected at indicated timepoints to assess Ctrough. |
At Baseline (Day 1), Days 8, 15, 22, 29, 43, 57, 85, 169, 253, 337, 365 and 395
|
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
- KP104-203
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?
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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