A study on patients with chronic kidney disease (CKD) to assess treatment experience and patterns, effect of the treatment, patient outcomes and patient quality of life
Study identifier:D1843R00291
ClinicalTrials.gov identifier:NCT04034992
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
An observational study collecting real-world data on patients with chronic kidney disease to assess: early treatment experience, treatment patterns, treatment effectiveness, patient outcomes and patient quality of life through prospective and retrospective data capture
Medical condition
Chronic Kidney Disease
Phase
N/A
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
1052
Study type
Observational
Age
18 Years - 130 Years
Date
Study Start Date: 11 Sept 2019
Estimated Primary Completion Date: 30 Jun 2023
Estimated Study Completion Date: 30 Jun 2023
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: -
Verification:
Verified 01 Jan 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Retrospective CKD cohort Retrospective (secondary) data refers to patient data extracted from existing electronic health records (EHRs)/registries/databases. It represents existing real-world data, regardless of reason for collection or location of storage and is analogous to those represented in the study protocol for which feasibility assessments are conducted. Retrospective data will be collected from registries, databases, and EHRs. The aim is to identify and extract clinical data retrospectively from a minimum of 100000 (no set maximum) CKD patients via existing databases/registries/EHRs across geographies. The retrospective data will be captured beginning 1 January 2008 through the most currently available data. | - |
| Prospective CKD cohort Prospective (primary and secondary) data refers to manual collection/extraction of data in a de novo manner for the purpose of addressing study objectives. Collection/extraction of patient data in the prospective cohort will be done via electronic case report form, questionnaires, and mobile phone/tablet application. The initial aim is to identify and collect/extract data from approximately 1000 (no set maximum) enrolled CKD patients until the decision to stop the study is taken, with the possibility of prospective follow-up for a minimum of approximately 1 year up to a maximum of approximately 3 years. The patient specific data in the prospective cohort will be collected by utilizing Rapid Assessment of Physical Activity (RAPA) questionnaire, Work Productivity and Activity Impairment (WPAI) questionnaire, Short Form (SF)-36 questionnaires, simple food diary, and other patient reported outcomes – including a set of questions to collect patient symptoms. | - |
