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

NCT04948424 | Completed

• 1 other identifier: Anaemia, retrospective
• Study Type: observational
• Target: 2,519
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (3)

• Anemia

  the incidence and prevalence of anemia; factors that predict the incidence of anemia

  June 1, 2016 to December 31, 2020

• Healthcare resource utilisation

  the number and percentage of patients who experienced all-cause hospitalisations.

  June 1, 2016 to December 31, 2020

• Select adverse clinical outcomes

  Such as mortality, MACE, modified MACE+

  June 1, 2016 to December 31, 2020

Secondary Outcomes (3)

• Compare the anemia-related index between patients with and without inflammation

  June 1, 2016 to December 31, 2020

• ESA responsiveness

  June 1, 2016 to December 31, 2020

• Select adverse clinical outcomes

  June 1, 2016 to December 31, 2020

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jie Dong

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Renal Division，Department of Medicine

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: January 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

CN (1)