AnemiaNCT04948424
A Retrospective Observational Study to Describe Anaemia Management, Burden of Disease and Outcomes in Chinese Patients on Peritoneal Dialysis Using a Clinical Database
An observational study of Anemia, run by Peking University First Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia
- How many people
- 2,519 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
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.
Read the 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.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
the incidence and prevalence of anemia; factors that predict the incidence of anemia
Measured: June 1, 2016 to December 31, 2020
Healthcare resource utilisation
the number and percentage of patients who experienced all-cause hospitalisations.
Measured: June 1, 2016 to December 31, 2020
Select adverse clinical outcomes
Such as mortality, MACE, modified MACE+
Measured: June 1, 2016 to December 31, 2020
Secondary outcomes (3)
Compare the anemia-related index between patients with and without inflammation
Anemia-related index for participants with and without inflammation
Measured: June 1, 2016 to December 31, 2020
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
Measured: June 1, 2016 to December 31, 2020
Select adverse clinical outcomes
Such as transfer to hemodialysis and peritonitis
Measured: June 1, 2016 to December 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jan 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Army Medical University, China, The First Affiliated Hospital of Zhengzhou University, Hebei Medical University Third Hospital, Peking University Shenzhen Hospital, Handan Central Hospital, Peking Haidian Hospital, People's Hospital of Qinghai Province, Cangzhou Central Hospital, The Second Affiliated Hospital of Harbin Medical University, Shengjing Hospital, The Second Hospital of Anhui Medical University, Peking University People's Hospital, The First Affiliated Hospital of BaoTou Medical College, Chuxiong Yi Autonomous Prefecture People's Hospital, Beijing miyun district hospital, Second Hospital of Shanxi Medical University, People's Hospital of Gansu, First Affiliated Hospital of Pingdingshan University, The First People's Hospital of Xining City, The First Hospital of Jilin University, Cangzhou People's Hospital, Taiyuan central hospital, People's hospital of Langfang, China Rehabilitation Research Center, Dongzhimen Hospital, Beijing, Department of Epidemiology and Biostatistics, School of Public Health, Peking University
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948424
- Sponsor's protocol ID
- Anaemia, retrospective
- Status last verified
- Dec 2022
- First submitted
- 24 Jun 2021
- Last updated
- 30 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04948424
- Acronym / sponsor ID
- Anaemia, retrospective
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,519 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Army Medical University, China, The First Affiliated Hospital of Zhengzhou University, Hebei Medical University Third Hospital, Peking University Shenzhen Hospital, Handan Central Hospital, Peking Haidian Hospital, People's Hospital of Qinghai Province, Cangzhou Central Hospital, The Second Affiliated Hospital of Harbin Medical University, Shengjing Hospital, The Second Hospital of Anhui Medical University, Peking University People's Hospital, The First Affiliated Hospital of BaoTou Medical College, Chuxiong Yi Autonomous Prefecture People's Hospital, Beijing miyun district hospital, Second Hospital of Shanxi Medical University, People's Hospital of Gansu, First Affiliated Hospital of Pingdingshan University, The First People's Hospital of Xining City, The First Hospital of Jilin University, Cangzhou People's Hospital, Taiyuan central hospital, People's hospital of Langfang, China Rehabilitation Research Center, Dongzhimen Hospital, Beijing, Department of Epidemiology and Biostatistics, School of Public Health, Peking University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anemia
Time frame: June 1, 2016 to December 31, 2020
the incidence and prevalence of anemia; factors that predict the incidence of anemia
Healthcare resource utilisation
Time frame: June 1, 2016 to December 31, 2020
the number and percentage of patients who experienced all-cause hospitalisations.
Select adverse clinical outcomes
Time frame: June 1, 2016 to December 31, 2020
Such as mortality, MACE, modified MACE+
3 secondary outcomes
Compare the anemia-related index between patients with and without inflammation
Time frame: June 1, 2016 to December 31, 2020
ESA responsiveness
Time frame: June 1, 2016 to December 31, 2020
Select adverse clinical outcomes
Time frame: June 1, 2016 to December 31, 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Dong principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: June 1, 2016 to December 31, 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.