A Retrospective Observational Study to Describe Anaemia Management, Burden of Disease and Outcomes in Chinese Patients on Peritoneal Dialysis Using a Clinical Database
NCT ID: NCT04948424
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2519 participants
OBSERVATIONAL
2022-01-01
2022-08-31
Brief Summary
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Detailed Description
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The overall objective is to describe the epidemiology, patient characteristics, treatment patterns relevant to anemia and clinical outcomes in patients on PD in real-world practice in China. Specifically, the incidence and prevalence of anemia will be estimated. The patient characteristics, medication use, select laboratory values and clinical outcomes, and healthcare resource utilization (HCRU) will be described in PD patients with and without anemia. The primary outcomes are 1) the incidence and prevalence of anemia, including the factors that predict the incidence of anemia; 2) the number and percentage of patients who experienced all-cause hospitalizations; 3) adverse clinical outcomes, such as mortality MACE and modified MACE+. The secondary outcomes are 1) hemoglobin levels or anemia, iron variables, medications on anemia management and clinical outcomes in patients with or without inflammation; 2) ESA responsiveness; 3) Other clinical outcomes, such as transfer to hemodialysis and peritonitis.
Associations between anemia, anemia-relevant factors and above clinical outcomes can be analyzed in series of paper with specific aims. For example, 1) the relationship between hemoglobin levels or anemia and clinical outcomes (such as mortality, MACE, modified MACE+, hospitalization, transfer to hemodialysis and peritonitis); 2) prognostic factors that predict the incidence of anemia during the follow up; 3) hemoglobin levels or anemia, iron variables, medications on anemia management and clinical outcomes in patients with or without inflammation; 4) the relationship between hemoglobin levels or anemia, erythropoietin responsiveness and clinical outcomes; 5) prognostic factors that predict the hyporesponsiveness to erythropoietin; 6) determine cut-off values of the iron index (such as serum iron, ferritin, TIBC and TSAT) to predicting worse clinical outcomes. Each study could select hemoglobin relevant variables including clinical characteristics and treatment patterns at baseline and/or during the follow up, and explore their associations with specific clinical outcomes.
Confounding, interaction or mediation effects could be evaluated. Subgroups, such as with or without diabetes, with or without CVD, with or without inflammation status et al could be analyzed as needed. Cox, competing risk models, Poisson or NegBin regression models may be used as needed.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with CKD with the first treatment/initiation of peritoneal dialysis between 1 June 2016 and 30 April 2019 with up to 2 years of follow-up data.
* Receiving PD for\>3 months
Exclusion Criteria
* Patients with diagnosises of any cancer (except for non-melanoma skin cancer) within 12 months prior to and inclusive of the baseline date
* Patients with evidence of active bleeding within 30 days and inclusive of the baseline date
* Patients with peritoneal dialysis switched from hemodialysis or renal transplantation failure
* Individuals receiving temporary PD (duration \< 30 days) because of acute kidney injury.
18 Years
80 Years
ALL
No
Sponsors
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The Second Hospital of Hebei Medical University
OTHER
Army Medical University, China
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Hebei Medical University Third Hospital
OTHER
Peking University Shenzhen Hospital
OTHER
Handan Central Hospital, Hebei
UNKNOWN
Peking Haidian Hospital
UNKNOWN
People's Hospital of Qinghai Province
UNKNOWN
Cangzhou Central Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Shengjing Hospital
OTHER
The Second Hospital of Anhui Medical University
OTHER
Peking University People's Hospital
OTHER
The First Affiliated Hospital of BaoTou Medical College
OTHER
The People's Hospital of Chuxiong Yi Autonomous Prefecture
UNKNOWN
Beijing miyun district hospital
UNKNOWN
Second Hospital of Shanxi Medical University
OTHER
People's Hospital of Gansu
UNKNOWN
Pingdingshan first people's Hospital
UNKNOWN
The first people's hospital of Xining
UNKNOWN
The First Hospital of Jilin University
OTHER
Cangzhou People's Hospital
OTHER
Taiyuan central hospital
UNKNOWN
People's hospital of Langfang
UNKNOWN
China Rehabilitation Research Center
OTHER_GOV
Dongzhimen Hospital, Beijing
OTHER
Department of Epidemiology and Biostatistics, School of Public Health, Peking University
UNKNOWN
Peking University First Hospital
OTHER
Responsible Party
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Dong Jie
Clinical Professor in Renal Division，Department of Medicine
Principal Investigators
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Jie Dong
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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Anaemia, retrospective
Identifier Type: -
Identifier Source: org_study_id