{"id":1934,"date":"2024-03-14T11:04:00","date_gmt":"2024-03-14T11:04:00","guid":{"rendered":"https:\/\/www.merckconnect.com\/prevymis\/?page_id=1934"},"modified":"2026-04-28T12:50:50","modified_gmt":"2026-04-28T12:50:50","slug":"kidney-transplant-study-design","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/prevymis\/kidney-transplant-study-design\/","title":{"rendered":"Study design"},"content":{"rendered":"\n\n

Study design in adult kidney transplant<\/strong> patients<\/strong><\/h1><\/div>\n\n\n\n\n
<\/div>\n\n\n\n

PREVYMIS\u00ae (letermovir) was studied in ~600 adult kidney transplant recipients at high risk (D+\/R-) for CMV disease<\/strong><\/h2><\/div>\n\n\n\n

Prophylaxis with PREVYMIS was assessed in a Phase 3 multicenter, double-blind, active comparator-controlled, non-inferiority clinical trial in 589 adult patients1<\/sup><\/p>\n\n\n\n

<\/div>\n\n\n\n

Primary efficacy endpoint: <\/strong>Incidence of CMV diseaseb<\/sup> through Week 52 post-transplant<\/p>\n\n\n\n\n

<\/div>
\"Study<\/picture>

<\/p><\/figcaption><\/figure><\/div>\n\n\n\n

(a) Study drug was administered orally or IV; dose of PREVYMIS was the same regardless of route of administration.<\/em><\/p>\n\n\n\n

(b) CMV end-organ disease or CMV syndrome, confirmed by an independent adjudication committee.<\/em><\/p>\n\n\n\n

<\/div>\n\n\n\n

Baseline patient characteristics and demographics<\/strong><\/h3><\/div>\n\n\n\n
<\/div>\n\n\n\n
Baseline characteristics<\/strong><\/td>Total population (N=589)<\/strong><\/td><\/tr>
Median age (range)<\/td>51 years (18 to 82 years)<\/td><\/tr>
Male<\/td>72%<\/td><\/tr>
Received kidney from deceased donor<\/td>60%<\/td><\/tr>
Race\/ethnicity<\/td><\/td><\/tr>
White<\/td>84%<\/td><\/tr>
Hispanic or Latino<\/td>17%<\/td><\/tr>
Black<\/td>9%<\/td><\/tr>
Multiple races<\/td>3%<\/td><\/tr>
Asian<\/td>2%<\/td><\/tr>
Alaskan native or American Indian<\/td>1%<\/td><\/tr>
Most common primary reasons for transplant<\/strong><\/td>Total population (N=589)<\/strong><\/td><\/tr>
Congenital cystic kidney disease<\/td>17%<\/td><\/tr>
Hypertension<\/td>16%<\/td><\/tr>
Diabetes\/diabetic nephropathy<\/td>14%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
<\/div>\n\n\n\n

See pediatric information for kidney transplant<\/a><\/p>\n\n\n\n

<\/div>\n\n\n\n

Reference<\/strong><\/h3><\/div>\n\n\n\n\n
  1. Limaye AP, Budde K, Humar A, et al. Letermovir vs valganciclovir for prophylaxis of cytomegalovirus in high-risk kidney transplant recipients: a randomized clinical trial. JAMA.<\/em> 2023;e239106. doi:10.1001\/jama.2023.9106<\/li><\/ol><\/div>\n\n\n\n
    <\/div>\n\n\n\n

    Back to top<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

    Prophylaxis with PREVYMIS was assessed in a Phase 3 multicenter, double-blind, active comparator-controlled, non-inferiority clinical trial in 589 adult patients1 Primary efficacy…<\/p>\n","protected":false},"author":699,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[270],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[285],"ga4_page_customer_journey_stage":[336],"ga4_page_customer_specialty":[361],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[576],"ga4_page_product":[599],"ga4_page_region":[910],"ga4_page_therapeuticarea":[],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-1934","page","type-page","status-publish"],"yoast_head":"\nStudy Design for Adult Kidney 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