- ICH GCP
- US Clinical Trials Registry
- 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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100034
- Peking University first hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anemia
Time Frame: June 1, 2016 to December 31, 2020
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the incidence and prevalence of anemia; factors that predict the incidence of anemia
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June 1, 2016 to December 31, 2020
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Healthcare resource utilisation
Time Frame: June 1, 2016 to December 31, 2020
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the number and percentage of patients who experienced all-cause hospitalisations.
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June 1, 2016 to December 31, 2020
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Select adverse clinical outcomes
Time Frame: June 1, 2016 to December 31, 2020
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Such as mortality, MACE, modified MACE+
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June 1, 2016 to December 31, 2020
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the anemia-related index between patients with and without inflammation
Time Frame: June 1, 2016 to December 31, 2020
|
Anemia-related index for participants with and without inflammation
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June 1, 2016 to December 31, 2020
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ESA responsiveness
Time Frame: June 1, 2016 to December 31, 2020
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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
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June 1, 2016 to December 31, 2020
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Select adverse clinical outcomes
Time Frame: June 1, 2016 to December 31, 2020
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Such as transfer to hemodialysis and peritonitis
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June 1, 2016 to December 31, 2020
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jie Dong, Peking University first hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anaemia, retrospective
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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