NCT05953701

Brief Summary

This study is a national secondary data analysis to determine the prevalence of diagnosed and undiagnosed CKD in German primary care offices in a patient population at high risk for the development and progression of CKD. Furthermore, it addresses the question of how CKD screening, monitoring and treatment of these patients is conducted within the German primary care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800,211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 28, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

June 28, 2023

Last Update Submit

March 17, 2025

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney DiseasesCKDSGLT2i

Outcome Measures

Primary Outcomes (4)

  • Percentage of patients with diagnosed CKD

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients with undiagnosed CKD

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients with undiagnosed or diagnosed CKD

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes)

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Dating back a maximum of 24 months from the date of first data transfer

Secondary Outcomes (20)

  • Average number of serum creatinine measurements per patient per year (52 weeks) in the study period

    Dating back a maximum of 24 months from the date of first data transfer

  • Average number of UACR measurements per patient per year (52 weeks) during the study period

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients who did not have serum creatinine and UACR determined at least once

    Dating back a maximum of 24 months from the date of first data transfer

  • +15 more secondary outcomes

Other Outcomes (8)

  • Percentage of patients among patients with diagnosed / undiagnosed CKD with at least one measurement of serum creatinine and UACR once per year (as recommended by KDIGO or ADA) in the study period

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients among patients with diagnosed / undiagnosed CKD that reached target values for blood pressure (as recommended by KDIGO) within 6 month (26 weeks) after index date

    Dating back a maximum of 24 months from the date of first data transfer

  • Percentage of patients among patients with diagnosed / undiagnosed CKD with guideline adherent medication as recommended by KDIGO, ADA or DEGAM within 6 month (26 weeks) after index date

    Dating back a maximum of 24 months from the date of first data transfer

  • +5 more other outcomes

Eligibility Criteria

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

This study includes adult patients with type 1 diabetes, type 2 diabetes and/or hypertension and/or cardiovascular disease

You may qualify if:

  • Age ≥ 18 years at start of the patient´s observation period
  • Having at least one of the following diseases (based on the documented ICD-10 code):
  • Type 1 diabetes
  • Type 2 diabetes
  • Hypertension
  • Cardiovascular disease, including:
  • Coronary and/or other atherosclerosis
  • Myocardial infarction
  • Heart failure
  • Peripheral arterial disease
  • Arrythmia
  • Stroke
  • Having at least one year (52 weeks) of observation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Koblenz, Germany

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
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 20, 2023

Study Start

July 26, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 19, 2025

Record last verified: 2025-03

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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes indicates that AZ is accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
More information

Locations

DE(1)