check_circleStudy Completed

Diabetic kidney disease

Bayer Identifier:

20011

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
A retrospective cohort study on treatment patterns and burden of disease using Japanese claims database in patient with Diabetic Kidney Disease

Trial purpose

The primary objective is to describe patient profile and health outcomes in DKD cohort and describe MRA treatment characteristics in a MRA sub-cohort. The secondary objective is to evaluate health care resource utilizations and costs in DKD cohort.

Key Participants Requirements

Sex

All

Age

N/A N/A
  • For DKD cohort:
    - Patients who have a claim with a diagnosis of DM (ICD-10: E10-E14)
    - Patients with the evidence of CKD (eGFR less than 60 ml/min/1.73m2) during the study period
    - Patients must have DM drugs during pre-index period or index month

    For MRA cohort:
    - Patients with a claim for a MRA drug during the study period any time after their DKD index date. Index date was defined as the first MRA prescription after their
    DKD index date

  • For DKD cohort:
    - Patients who do not have at least 2 claims within the 1 year follow up period
    - Patients who do not have at least 1 claim within the 6 months pre-index period
    - Patients with a diagnosis of ESRD, PKD, or IGA within the pre-index period
    For MRA cohort:
    - Patients who do not have at least 2 claims within the 1 year follow up period
    - Patients who do not have at least 1 claim within the pre-index period
    - Patients with a diagnosis of ESRD, PKD, or IGA within the pre-index period

Trial summary

Enrollment Goal
19582
Trial Dates
November 2018 - December 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Japan

Primary Outcome

  • Time to first occurrence of events
    Days from cohort index date to the first occurrence of the following events: - Hyperkalemia - Renal related events (Renal failure, Reduction of eGFR ≥ 40% from baseline) - Cardiovascular (CV)-related events (non-fatal myocardial infarction, non-fatal stroke, unstable angina, atrial fibrillation or atrial flutter, hospitalization for heart failure, or composite CV events) - Death
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Change of eGFR value from baseline during every follow-up month of the study period
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Duration of initial Mineralocorticoid receptor antagonist (MRA) treatment
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Medication possession ratio (MPR) for MRA treatments
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Adherence to MRA treatment
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Discontinuation of MRA treatment
    Patients who have gap of 90 days or more in treatment with MRAs.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Discontinuation of MRA treatment due to hyperkalemia
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Duration of initial MRA treatment
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016

Secondary Outcome

  • Total health care resource utilization (HCRU) and total annual direct medical cost per patient
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Number of visits and total cost for outpatient visits per patient
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Number of visits and total cost for inpatient admissions per patient
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Average duration of inpatient admissions per patient
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Number of visits and total cost for emergency room visits per patient
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016
  • Number of claims for any lab tests (monitoring)
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Apr-2008 to 31-Aug-2016

Trial design

A retrospective cohort study on treatment patterns and burden of disease using Japanese claims database in patient with Diabetic Kidney Disease
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here to find results for studies related to Bayer products.