A Retrospective Observational Study to Describe Anaemia Management, Burden of Disease and Outcomes in Chinese Patients on Peritoneal Dialysis Using a Clinical Database

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948424
• Other study ID #: Anaemia, retrospective
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2519
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (28)

Lead Sponsor

Collaborator

Peking University First Hospital

Beijing miyun district hospital, Cangzhou Central Hospital, Cangzhou People's Hospital, China Rehabilitation Research Center, Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Dongzhimen Hospital, Beijing, Handan Central Hospital, Hebei, Hebei Medical University Third Hospital, Peking Haidian Hospital, Peking University People's Hospital, Peking University Shenzhen Hospital, People's Hospital of Gansu, People's hospital of Langfang, People's Hospital of Qinghai Province, Pingdingshan first people's Hospital, Second Hospital of Shanxi Medical University, Shengjing Hospital, Taiyuan central hospital, The First Affiliated Hospital of BaoTou Medical College, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, The first people's hospital of Xining, The People's Hospital of Chuxiong Yi Autonomous Prefecture, The Second Affiliated Hospital of Harbin Medical University, The Second Hospital of Anhui Medical University, The Second Hospital of Hebei Medical University, Xinqiao hospital of Army Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	the incidence and prevalence of anemia; factors that predict the incidence of anemia	June 1, 2016 to December 31, 2020
Primary	Healthcare resource utilisation	the number and percentage of patients who experienced all-cause hospitalisations.	June 1, 2016 to December 31, 2020
Primary	Select adverse clinical outcomes	Such as mortality, MACE, modified MACE+	June 1, 2016 to December 31, 2020
Secondary	Compare the anemia-related index between patients with and without inflammation	Anemia-related index for participants with and without inflammation	June 1, 2016 to December 31, 2020
Secondary	ESA responsiveness	Such as describing trajectories of Hb level and ESA dose post-ESA initiation and explore the relationship among erythropoietin responsiveness, hemoglobin levels and clinical outcomes	June 1, 2016 to December 31, 2020
Secondary	Select adverse clinical outcomes	Such as transfer to hemodialysis and peritonitis	June 1, 2016 to December 31, 2020