Letermovir vs Valganciclovir in CMV R+ Kidney Transplant
Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
- Is letermovir easier for patients to tolerate than valganciclovir?
- How long does it take for a CMV infection to appear in each group?
- Are there differences in "breakthrough" CMV infections between the two medications?
- For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
調査の概要
詳細な説明
The purpose of this study is to evaluate the efficacy and tolerability of letermovir compared to standard-of-care, valganciclovir, for the prevention of clinically significant cytomegalovirus (CMV) infection in CMV moderate risk adult kidney transplant recipients.
A 3:1 match of historical valganciclvoir:letermovir arm
• Matching criteria:
- Induction agent: lymphocyte-depleting (rabbit anti-thymocyte globulin or alemtuzumab) versus non-lymphocyte depleting (basiliximab)
- Delayed graft function (dialysis within one week of kidney transplant)
- MMF dose at de novo discharge (weight-based vs non-weight based)
Study Arms:
Letermovir Arm:
- Letermovir 480 mg PO daily starting POD 4 through 10 OR
- Letermovir 240 mg PO daily if given concomitantly with cyclosporine, for 90 days
- Will be given with acyclovir 400 mg PO BID (or 200 PO BID if CrCl <25) for 90 days
Historical Arm:
Valganciclovir 450 mg PO daily (adjusted for renal function) for 90 days
- CrCl 25-30: valganciclovir 450 mg PO q 48 h
- CrCl <25: Valganciclovir 450 mg PO three times weekly
Outcomes:
Primary Efficacy Objective:
Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir
- Clinically Significant CMV Infection: CMV disease or symptomatic viremia requiring therapeutic intervention
Secondary Objectives:
Tolerability:
- Proportion of patients with leukopenia or neutropenia (composite) in patients who received letermovir versus standard of care valganciclovir
- Leukopenia: white blood cells < 3500 cells/uL
Neutropenia: absolute neutrophil count < 1000 cells/uL
- Intolerability or early drug discontinuation
Proportion of patients who discontinue the study drug prematurely due to adverse events or intolerance
o Efficacy:
- Time-to clinically significant CMV infection (days)
- Breakthrough CMV while on CMV prophylaxis
CMV Viremia
- Detection of CMV DNA in blood via PCR
Clinically significant CMV infection
- CMV resistance
- Detection of CMV strains with genotypic or phenotypic resistance to antiviral agents used in prophylaxis or treatment
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：Elisabeth Kincaide, PharmD
- 電話番号：210-743-4086
- メール：Elisabeth.Kincaide@uhtx.com
研究連絡先のバックアップ
- 名前：Sean Moore, BSN, RN
- 電話番号：210-475-2559
- メール：Sean.Moore2@uhtx.com
研究場所
-
-
Texas
-
San Antonio、Texas、アメリカ、78229
- University Hospital
-
コンタクト：
- Elisabeth Kincaide, PharmD
- 電話番号：210-743-4086
- メール：Elisabeth.Kincaide@uhtx.com
-
コンタクト：
- Sean Moore, BSN, RN
- 電話番号：210-475-2559
- メール：Sean.Moore2@uhtx.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
説明
Inclusion Criteria (both arms):
- ≥18 years old
- Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
Inclusion Criteria (letermovir arm):
- Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
- Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation
Exclusion Criteria (both arms):
- Multiorgan organ transplant
- Received previous solid organ transplant or HSCT
- Unable to take oral medications
- Uncontrolled infections at the time of enrollment
- Hemodynamically unstable or on mechanical ventilation at the time of enrollment
- Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor
- Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation
- Received any anti-CMV drug treatment within 7 days prior to enrollment
- Current user of recreational or illicit drugs or alcohol dependence
- History of CMV disease prior to enrollment
Exclusion Criteria (letermovir arm):
- Previously participated in a letermovir study or any other study with CMV investigational agents
- On dialysis or plasmapheresis at the time of enrollment
- Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations
- Child-Pugh Class C severe hepatic insufficiency
- Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study
- Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine
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：防止
- 割り当て：非ランダム化
- 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：Letermovir
Prospective letermovir prophylaxis
|
Letermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant
|
|
他の：Valganciclovir
Historical valganciclovir prophylaxis
|
Valganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)
|
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 |
|---|---|---|
|
CMV Infection
時間枠：12 months post kidney transplant
|
Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.
|
12 months post kidney transplant
|
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
- STUDY00000831
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
米国で製造され、米国から輸出された製品。
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