NCT05932901

Brief Summary

This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,682,052

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

May 5, 2023

Last Update Submit

April 16, 2024

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (11)

  • Baseline demographics

    Patient demographic characteristics including age, sex, race and insurance type (if data are available)

    1 year pre-index

  • Baseline clinical characteristics

    Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke

    1 year pre-index

  • Baseline comedications

    Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia

    1 year pre-index

  • Baseline eGFR in ml/min/1.73m2

    Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

  • Baseline uACR in mg/g

    Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

  • Baseline serum creatinine in mg/dl

    Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

  • Baseline calcium in mg/dl

    Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

  • Baseline sodium in mmol/L

    Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

  • Baseline hemoglobin A1c in %

    Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

  • Baseline hematocrit in %

    Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum, % patients with value \<40

    1 year pre-index

  • Baseline systolic blood pressure in mmHg

    Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum

    1 year pre-index

Secondary Outcomes (4)

  • Proportion of patients who initiate cardiorenal protective medication

    1 year post-index

  • Proportion of patients who continue cardiorenal protective medication

    1 year post-index

  • Proportion of patients with hospitalisations following incident CKD index

    1 year post-index

  • Average healthcare cost for specific outcomes/reasons

    1 year post-index

Study Arms (3)

Dapagliflozin 10mg initiators

Adult patients (aged ≥18 years) with chronic kidney disease, who received a dapagliflozin 10mg prescription on or after the country-specific CKD indication approval date, and who did not previously have a prescription for dapagliflozin.

Dapagliflozin 10mg eligible but untreated

Adult patients (aged ≥18 years) with chronic kidney disease, who meet the country-specific approved dapagliflozin 10mg treatment criteria for CKD on or after the local CKD indication approval date, but have not received a prescription

Incident CKD

Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period.

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The overall study population will consist of adult (aged \> 18 years) patients with CKD

You may qualify if:

  • Adult patients (aged ≥18 years)
  • Chronic kidney disease (diagnosis code, uACR \>30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
  • ≥365 days continuous enrolment in database

You may not qualify if:

  • History of type 1 diabetes, gestational diabetes or dialysis
  • History of dapagliflozin 10mg prescriptions before index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Minneota, Minnesota, 13625, United States

Location

Research Site

Kyoto, Kyoto, 604-0086, Japan

Location

Research Site

Tokyo, 101-0053, Japan

Location

Research Site

Uppsala, 75320, Sweden

Location

Research Site

Uppsala, 75322, Sweden

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

July 6, 2023

Study Start

May 4, 2022

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(1)JP(2)SE(2)