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I am your "go to" English-Spanish Translator. I am here to help you communicate your message to the desired audience in a time-efficient and detail-oriented manner.
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English to Spanish: Clinical Study Protocol General field: Medical
Source text - English CLINICAL STUDY PROTOCOL
Title:
A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
Number: TRCA-305 (VALOR-CKD)
OBJECTIVES:
To evaluate the effect of TRC101 on the progression of chronic kidney disease and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
POPULATION:
This study will enroll male and female subjects, 18 to 80 years of age with non-dialysis-dependent CKD, an estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.72m2 and a serum bicarbonate value of 12 to 20 mEq/L. Eligible subjects will be enrolled into the single-blind 2- to 4-week Part A of the study in order to randomize approximately 1,500 subjects into the placebo-controlled Part B.
DESIGN AND DURATION:
This study will compare the efficacy of TRC101 to placebo. Serum bicarbonate will be measured onsite from a whole (venous) blood sample using an i-STAT point-of-care device. The primary endpoint will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death.
Translation - Spanish PROTOCOLO DE ESTUDIO CLÍNICO
Título:
Estudio en fase 3b, aleatorizado, doble ciego, controlado por placebo para evaluar la eficacia y la seguridad de TRC101 en retrasar la progresión de la enfermedad renal crónica en sujetos con acidosis metabólica
Número: TRCA-305 (VALOR-ERC)
OBJETIVOS:
Evaluar el efecto de TRC101 en la progresión de la enfermedad renal crónica (ERC) y determinar el perfil de seguridad de TRC101 en pacientes con ERC y acidosis metabólica.
POBLACIÓN:
En este estudio, se incorporará a hombres y mujeres de entre 18 y 80 años de edad con ERC no dependiente de diálisis, una tasa de filtración glomerular estimada (TFGe) de entre 20 y 40 mL/min/1.72m2 y concentración de bicarbonato sérico de entre 12 a 20 mEq/L. Los pacientes aptos participarán en la Fase A del estudio de simple ciego, de 2 a 4 semanas de duración, para aleatorizar aproximadamente a 1500 sujetos para la Fase B controlada por placebo.
DISEÑO Y DURACIÓN:
En este estudio, se comparará la eficacia de TRC101 con el placebo. El bicarbonato sérico se medirá en el centro a partir de una muestra de sangre (venosa) obtenida mediante el dispositivo portátil i-STAT. El criterio de valoración principal será la progresión de la enfermedad renal, definida como el tiempo transcurrido entre la primera aparición de cualquier evento incluido en el criterio de valoración compuesto, que consiste en una reducción confirmada de la TFGe ≥40 %, enfermedad renal terminal (ERT) y muerte por causas renales.
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Translation education
Bachelor's degree - Universidad del Salvador
Experience
Years of experience: 11. Registered at ProZ.com: Aug 2019. Became a member: Aug 2019.
Credentials
English to Spanish (Instituto Superior New Start D-130) English to Spanish (Universidad del Salvador, Facultad de Filosofía, Historia y Letras, verified) Spanish to English (Universidad del Salvador, Facultad de Filosofía, Historia y Letras, verified)
Memberships
N/A
Software
memoQ, MemSource Cloud, Microsoft Word, Smartling, Smartcat, Smartling, Trados Studio, Wordfast
My name is Carina, I am your "go to" English-Spanish Translator.
I am here to deliver your message to your desired audience in a time-efficient, detail-oriented and proactive manner. My main areas of expertise are life-science, medical, marketing and legal texts. However, I am always in the search for new challenges in the translation industry.
I have worked both as a freelance and as an in-house translator. Therefore, I was able to gain experience on the best of both worlds!
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Member since Aug '19
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