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AstraZenecaA Prospecitve Multicenter, Observational Registry Study 3000 Observacional
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07481526 es un estudio observacional para Enfermedad renal crónica. Su estado actual es: reclutando. El estudio se inició el 27 de febrero de 2026, con el objetivo de reclutar a 3000 participantes. Dirigido por AstraZeneca, se espera que finalice el 30 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 19 de marzo de 2026.
Resumen
This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.
Descripción detallada
To ensure a nationally representative cohort, a total of approximately 3000 participants will be enrolled from around 80 sites strategically selected from various geographic regions in China. The sites will include a mix of top-tier tertiary hospitals, regional medical centers, and representative secondary hospitals to accurately reflect real-world clinical practice at different levels of care. All enrolled participa...Mostrar más
Título oficial
A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease
Condiciones médicas
Enfermedad renal crónicaOtros ID del estudio
- D4327R00004
Número del NCT
Inicio del estudio (real)
2026-02-27
Última actualización
2026-03-19
Fecha de finalización (estimada)
2028-12-30
Inscripción (prevista)
3000
Tipo de estudio
Observacional
Estado general
Reclutando
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively | To determine the prevalence of HP, HF, HTN, and HK among patients with CKD | baseline |
Adoption rate of medications (e.g., Endothelin receptor antagonists [ERA], MRA, RASi, SGLT2i) | To describe the treatment patterns in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of eGFR slope in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the clinical composite outcome of eGFR decline ≥50% for CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the clinical composite outcome of End-stage renal disease(ESRD) for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the clinical composite outcome of renal death for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the clinical composite outcome of CV death for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the renal outcome of ≥50% eGFR decline from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the renal outcome of ESRD from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the renal outcome of RRT(renal replacement therapy) from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the renal outcome of CKD stage progression for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the renal outcome of Renal-related death for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the CV outcome of MACE(major adverse cardiovascular events) for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the CV outcome of HF for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe the CV outcome of CV death (included in the composite of renal or CV death) for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe all-cause death for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK | To describe all-cause hospitalization for all CKD patients and subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients with HK | To describe HK outcomes of HK recurrence for all CKD patients with HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients with HK | To describe HK outcomes of Severe HK requiring hospitalisation for all CKD patients with HK. | Week 0 to week 96 |
Clinical outcomes of CKD patients with HK | To describe HK outcomes of Severe HK requiring emergency-department visits for all CKD patients with HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of change in eGFR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of Change in UACR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of Change in UPCR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of Change in UPER from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of Proportion of patients achieving UACR \<700 mg/g with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of Proportion of patients achieving UPCR \< 1000 mg/g and ≥ 30% reduction from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK | To describe the clinical indicators of Proportion of patients achieving UPER \<1000 mg/24h with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK. | Week 0 to week 96 |
Clinical indicators for CKD patients with HP and HTN | To describe the clinical indicators of Change in systolic BP from baseline over time in patients with CKD and subgroups of HP and HTN. | Week 0 to week 96 |
Clinical indicators for CKD patients with HP and HTN | To describe the clinical indicators of Change in diastolic BP from baseline over time in patients with CKD and subgroups of HP and HTN. | Week 0 to week 96 |
Clinical indicators for CKD patients with HP and HTN | To describe the clinical indicators of Proportion of patients achieving BP control target over time in patients with CKD and subgroups of HP and HTN. | Week 0 to week 96 |
Clinical indicators for CKD patients with HF | To describe the clinical indicators of Change of NT-proBNP from baseline over time in patients with CKD with HF. | Week 0 to week 96 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of eGFR slope between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
The HCRU among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | To describe healthcare resource utilization (HCRU) among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicators eGFR slope in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of Composite outcome of eGFR decline ≥50% between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of Change in eGFR from baseline over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of change in UACR from baseline over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of change in UPCR from baseline over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of change in UPER from baseline over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of proportion of patients achieving UACR \<700 mg/g with ≥30% reduction over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of Proportion of patients achieving UPER \<1000 mg/24h with ≥30% reduction over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP and HTN | To compare the clinical indicators of Change in systolic BP from baseline over time between CKD patients with or without HP, HTN | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP and HTN | To compare the clinical indicators of change in diastolic BP from baseline over time between CKD patients with or without HP, HTN | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP and HTN | To compare the clinical indicators of proportion of patients achieving BP control target over time between CKD patients with or without HP, HTN | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HF | To compare the clinical indicators of Change of NT-proBNP from baseline over time between CKD patients with or without HF | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of change in eGFR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of change in UACR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of change in UPCR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of change in UPER from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of proportion of patients achieving UACR \<700 mg/g with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of proportion of patients achieving UPCR \< 1000 mg/g and ≥ 30% reduction from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of proportion of patients achieving UPER \<1000 mg/24h with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of change in systolic BP from baseline over time in patients with CKD overall, and in subgroups with HP,HTN | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of change in diastolic BP from baseline over time in patients with CKD overall, and in subgroups with HP,HTN | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups | To identify the factors associated with the clinical indicator of Proportion of patients achieving BP control target over time in patients with CKD overall, and in subgroups with HP,HTN | Week 0 to week 96 |
The factors associated with the clinical indicators in patients with CKD overall, and in subgroups of HF | To identify the factors associated with the clinical indicator of change of NT-proBNP from baseline over time in patients with CKD overall, and in subgroups with HF | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the composite outcome of eGFR decline ≥50% in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the composite outcome of ESRD in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the composite outcome of renal death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the composite outcome of CV death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the renal outcomes of ≥50% eGFR decline from baseline in patients with CKD overall, and in subgroups with HP,HTN | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the renal outcomes of ESRD in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the renal outcomes of RRT in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with the renal outcomes of CKD stage progression in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with renal-related death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with CV outcomes of MACE in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with CV outcomes of HF in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with CV outcomes of CV death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with CV outcomes of all-cause death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with CV outcomes of all-cause hospitalization in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HK | To identify the factors associated with HK outcomes of HK recurrence in patients with CKD overall, and in subgroups with HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HK | To identify the factors associated with HK outcomes of severe HK requiring hospitalisation in patients with CKD overall, and in subgroups with HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HK | To identify the factors associated with HK outcomes of severe HK requiring emergency-department visits in patients with CKD overall, and in subgroups with HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of composite outcome of ESRD between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of composite outcome of renal death between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of composite outcome of CV death between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of Renal outcomes of ≥50% eGFR decline from baseline between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of Renal outcomes of ESRD between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of Renal outcomes of RRT between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of CKD stage progression between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of Renal-related death between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of CV outcomes of MACE between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of CV outcomes of hHF between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of All-cause death between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical outcomes of All-cause hospitalization between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HK | To compare the clinical outcomes of HK recurrence between CKD patients with or without HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HK | To compare the clinical outcomes of Severe HK requiring hospitalisation between CKD patients with or without HK | Week 0 to week 96 |
Clinical outcomes of CKD patients and CKD patients with HK | To compare the clinical outcomes of Severe HK requiring emergency-department visits between CKD patients with or without HK | Week 0 to week 96 |
Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK | To compare the clinical indicators of proportion of patients achieving UPCR \< 1000 mg/g and ≥ 30% reduction from baseline over time between CKD patients with or without HP, HF, HTN, HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with All-cause death in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
The factors associated with the clinical outcomes in patients with CKD overall, and in subgroups of HP, HF, HTN, and HK | To identify the factors associated with all-cause hospitalization in patients with CKD overall, and in subgroups with HP, HF, HTN, and HK | Week 0 to week 96 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto, Adulto mayor
Criterios de sexo
Todos
Male or female patients aged ≥18 years.
Willing and able to provide written informed consent to participate in the study.
Confirmed CKD diagnosis at enrolment, defined by at least one of the following:
- eGFR <60 mL/min/1.73 m² for ≥3 months, OR
- Evidence of kidney damage (e.g., UACR ≥30 mg/g or UPCR ≥150 mg/g, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months
- Having a life-threatening comorbidity with life expectancy < 2 years.
- Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.
- Pregnant or breastfeeding women.
- Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.
- Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.
AstraZenecaContactos centrales del estudio
Contacto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
1 Centros del estudio en 1 países
Zhongshan Hospital Affilicated with Fudan University, Shanghai, China
Reclutando