Efficacy and Safety of Weekly Subcutaneous MLN1202 in Improving Diabetic Nephropathy in Participants With Macroalbuminuria
A Multicenter, Randomized, Double Blind, Placebo Controlled, Proof of Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Weekly Subcutaneous MLN1202, in Improving Diabetic Nephropathy in Subjects With Macroalbuminuria
調査の概要
詳細な説明
The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat people who have diabetes with macroalbuminuria. This study will look at the urinary albumin-to-creatinine ratio in people who take MLN1202.
The study will enroll approximately 156 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- MLN1202 75 mg subcutaneous (SC) injection
- MLN1202 105 mg SC injection
- MLN1202 150 mg SC injection
- Placebo matching MLN1202 SC injection (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient
All participants will receive a loading dose of placebo or MLN1202 on Day 1 followed by once-weekly injections of the study medication they were randomized to receive.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 5 months. Participants will make multiple visits to the clinic, plus a final visit 5 weeks after the last dose of study drug for a follow-up assessment.
研究の種類
段階
- フェーズ2
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:
- In the opinion of the investigator, the participant is capable of giving informed consent to enter the trial, including understanding and complying with protocol requirements.
- The participant or, when applicable, (eg, where the subject is capable of giving verbal informed consent to enter the trial but cannot physically sign a written, informed consent form), the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- At the time of Screening the participant is male or female and aged 18-90 years inclusive at first dose of study medication.
- Was previously diagnosed with type 2 diabetes mellitus per American Diabetes Association criteria.
- Has an estimated glomerular filtration rate (eGFR) based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of 25-59 mL/min/1.73 m(2) at Screening.
- Has been on a stable dose of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for 8 weeks prior to Screening.
- Has residual albuminuria despite stable treatment with an ACE inhibitor or an ARB for at least 8 weeks prior to Screening (albumin:creatinine ratio [ACR] of > 300 mg/g creatinine, inclusive at Screening).
- Has glycosylated hemoglobin (HbA1c) less than or equal to 10.5% at screening.
- If a subject is regularly using dipeptidyl peptidase-4 inhibitor (DPP-4i) or sodium-glucose cotransporter 2 inhibitor (SGLT2i) to treat diabetes, he/she has been on a stable dose and regimen within 2 months prior to Screening.
- All participants who are not surgically sterile or post-menopausal, or whose partners are not surgically-sterile or postmenopausal, must use two effective birth control methods or abstain from intercourse during this study.
Exclusion Criteria:
- Has received any investigational compound within 90 days prior to Screening.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Is taking any combination of dual renin-angiotensin system (RAS) inhibition (such as an ACE inhibitor and an ARB or an ACE inhibitor and a mineralocorticoid receptor antagonist).
- Has type 1 diabetes mellitus or a history of ketoacidosis.
- Has poorly-controlled blood pressure (systolic blood pressure >160 or diastolic blood pressure >110, with blood pressure measured in the seated position after at least 5 minutes of rest) at Screening and Day 1.
- Has received dialysis within 3 months of Screening.
- Has infectious diseases or leg ulcers at Screening (all per discretion of Principal Investigator [PI]).
- Has severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study.
- Has known infection with human immunodeficiency virus (HIV), or a positive test for Hepatitis B, Hepatitis C, or tuberculosis (TB) at Screening. Subjects who have a positive TB skin test at Screening must rule out active or latent tuberculosis documented by chest x-ray in order to be considered eligible for study participation.
- Has used long-term immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors within 2 weeks prior to Screening. Short-term use is defined as a duration of ≤4 weeks of continuous use.
- In the judgment of the principal investigator, participants who are likely to be non-compliant or uncooperative during the study.
- Has known non-diabetic kidney disease (such as autosomal dominant polycystic kidney disease (ADPCKD), Immunoglobulin A (IgA) nephropathy, focal segmental glomerulosclerosis, or obstructive uropathy). Hypertensive nephrosclerosis superimposed on diabetic kidney disease is acceptable.
- Had a previous renal transplant.
- Has hypersensitivity to other monoclonal antibodies (mAb) or to any component of the formulation of MLN1202.
- Has history of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
- Is symptomatic with dysuria, and has a positive urine culture at screening.
- If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period and for 56 days (8weeks) afterwards.
- If male, the subject intends to donate sperm during the course of this study or for 12 weeks thereafter.
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 |
---|---|
プラセボコンパレーター:Placebo
MLN1202 placebo-matching solution, subcutaneous injection (SC), once, on Day 1 (loading dose), followed by MLN1202 placebo-matching solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
MLN1202 placebo-matching solution for SC injection
|
実験的:MLN1202 75 mg
MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 75 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
MLN1202 solution for SC injection
|
実験的:MLN1202 105 mg
MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 105 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
|
MLN1202 solution for SC injection
|
実験的:MLN1202 150 mg
MLN1202 450 mg, solution, SC injection, once, on Day 1 (loading dose), followed by MLN1202 150 mg, solution, SC, once, weekly, on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
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MLN1202 solution for SC injection
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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 |
---|---|---|
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Day 85
時間枠:Baseline and Day 85
|
UACR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids.
First morning void is defined as a void upon awakening and before beginning daily activities.
|
Baseline and Day 85
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Over Time
時間枠:Baseline and Days 29, 57, 85, and 113
|
For Days 29 and 57 UACR will be evaluated from a single first morning void.
For Days 85 and 113 UACR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids.
First morning void is defined as a void upon awakening and before beginning daily activities.
|
Baseline and Days 29, 57, 85, and 113
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Change from Baseline in Urinary Protein:Creatinine Ratio (UPCR) Over Time
時間枠:Baseline and Days 29, 57, 85, and 113
|
For Days 29 and 57 UPAR will be evaluated from a single first morning void.
For Days 85 and 113 UPCR will be calculated using the geometric mean of 3 consecutive days first in the morning urine voids.
First morning void is defined as a void upon awakening and before beginning daily activities.
|
Baseline and Days 29, 57, 85, and 113
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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 (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 (見積もり)
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
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。
MLN1202 Placeboの臨床試験
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Palacky University完了
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Millennium Pharmaceuticals, Inc.完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア