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Completed

NCT Number: NCT05932901

OPTIMISE-CKD Drug Utilization

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).

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Kyoto, Japan

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About this study

OPTIMISE-CKD is an 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).

Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.

Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:

  • Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
  • Describing selected outcomes among overall, treated and untreated incident CKD patients.

Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Baseline demographics

    Time frame: 1 year pre-index

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

  2. Baseline clinical characteristics

    Time frame: 1 year pre-index

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

  3. Baseline comedications

    Time frame: 1 year pre-index

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

  4. Baseline eGFR in ml/min/1.73m2

    Time frame: 1 year pre-index

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

  5. Baseline uACR in mg/g

    Time frame: 1 year pre-index

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

  6. Baseline serum creatinine in mg/dl

    Time frame: 1 year pre-index

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

  7. Baseline calcium in mg/dl

    Time frame: 1 year pre-index

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

  8. Baseline sodium in mmol/L

    Time frame: 1 year pre-index

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

  9. Baseline hemoglobin A1c in %

    Time frame: 1 year pre-index

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

  10. Baseline hematocrit in %

    Time frame: 1 year pre-index

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

  11. Baseline systolic blood pressure in mmHg

    Time frame: 1 year pre-index

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

Secondary outcomes

  1. Proportion of patients who initiate cardiorenal protective medication

    Time frame: 1 year post-index

    Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date

  2. Proportion of patients who continue cardiorenal protective medication

    Time frame: 1 year post-index

    Treatment persistence (RASi and/or SGLT2i/dapagliflozin 10mg) following initiation after incident CKD index date

  3. Proportion of patients with hospitalisations following incident CKD index

    Time frame: 1 year post-index

    Hospitalisations (any reason, CKD, heart failure) following incident CKD index

  4. Average healthcare cost for specific outcomes/reasons

    Time frame: 1 year post-index

    Healthcare costs related to hospitalisation for CKD, heart failure, atherosclerotic CVD following incident CKD index

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease

Acronym: OPTIMISE-CKD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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