Clinical trial NCT04948424: A Retrospective Observational Study to Describe Anaemia Management, Burden of Disease and Outcomes in Chinese Patients on Peritoneal Dialysis Using a Clinical Database
Official title: A Retrospective Observational Study to Describe Anaemia Management, Burden of Disease and Outcomes in Chinese Patients on Peritoneal Dialysis Using a Clinical Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Army Medical University, China
name: The First Affiliated Hospital of Zhengzhou University
name: Hebei Medical University Third Hospital
name: Peking University Shenzhen Hospital
name: Handan Central Hospital, Hebei
name: Peking Haidian Hospital
name: People's Hospital of Qinghai Province
name: Cangzhou Central Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Shengjing Hospital
name: The Second Hospital of Anhui Medical University
name: Peking University People's Hospital
name: The First Affiliated Hospital of BaoTou Medical College
name: The People's Hospital of Chuxiong Yi Autonomous Prefecture
name: Beijing miyun district hospital
name: Second Hospital of Shanxi Medical University
name: People's Hospital of Gansu
name: Pingdingshan first people's Hospital
name: The first people's hospital of Xining
name: The First Hospital of Jilin University
name: Cangzhou People's Hospital
name: Taiyuan central hospital
name: People's hospital of Langfang
name: China Rehabilitation Research Center
name: Dongzhimen Hospital, Beijing
name: Department of Epidemiology and Biostatistics, School of Public Health, Peking University
First posted: 2021-07-02
Enrollment: 2519
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is primarily descriptive and all patients meeting the inclusion criteria will be included. We expect to analysis data on approximately 2000 to 2500 peritoneal dialysis patients.

Brief summary: The overall objective is to describe the epidemiology, health care resource utilisation (HCRU) and selected clinical outcomes in patients initiating PD by anaemia status in real-world setting in China.

Detailed description: Real-world evidence for chronic kidney disease (CKD)-associated anemia in China is scarce. This study aims to provide supporting novel evidence for the real-world management and treatment of patients on PD with CKD-associated anemia. This is an observational cohort study using secondary data. The data source is the PD Telemedicine-based Management Platform (PDTAP) database, which is a clinical database that prospectively collects data in patients receiving PD and evaluates PD management and clinical practice in China. The PDTAP database has enrolled around 7,000 patients receiving PD from 27 hospitals in 14 provinces located in all seven geographical regions (northwest, northeast, north, central, southwest, southeast and south) in China.

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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years old at the initiation of peritoneal dialysis
* 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 missing age or sex information (proportion of missingness to be assessed)
* 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.

Primary outcomes:
measure: Anemia
timeFrame: June 1, 2016 to December 31, 2020
measure: Healthcare resource utilisation
timeFrame: June 1, 2016 to December 31, 2020
measure: Select adverse clinical outcomes
timeFrame: June 1, 2016 to December 31, 2020
Secondary outcomes:
measure: Compare the anemia-related index between patients with and without inflammation
timeFrame: June 1, 2016 to December 31, 2020
measure: ESA responsiveness
timeFrame: June 1, 2016 to December 31, 2020
measure: Select adverse clinical outcomes
timeFrame: June 1, 2016 to December 31, 2020
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jie Dong
role: PRINCIPAL_INVESTIGATOR
References: