Skip to main content
OpenTrials
Completed

NCT Number: NCT06614712

OPTIMISE-CKD Study_current Clinical Landscape in Spain

OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. The study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Seville, 41092, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥18 years as of study index date

  • With renal function measured as either of the following:
  • At least 1 UACR measure of ≥30 mg/g; OR
  • At least 2 eGFR measures taken ≥90 days apart, of which both eGFR is ≤75 ml/min/1.73m2 ; OR
  • registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation)

Exclusion criteria

  • History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period

Treatment and study plan

Pre-pricing & reimbursement, incident renal disease cohort (study observation period 2020- 2024)

Other

Incident renal disease patients in this cohort are defined as those that newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the start date of this cohort study period, the 1st August 2020 and until the 1 st February 2023 (DAPA_CKD P&R date in Spain). The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-1 of this study cohort.

At the index date-1, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines.

Patients will be followed up from the index date-1 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall observation period.

Post-pricing & reimbursement, incident renal disease cohort (study observation period 2023-2024)

Other

We define the post-P&R cohort including all incident renal disease patients observed in the dapagliflozin-CKD post-pricing and reimbursement period. Patients in this cohort newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the 1 st February 2023 (DAPA_CKD P&R date in Spain) and until the end of the study observation period. The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-2 of this study cohort. At the index date-2, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-2 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall study period

Primary outcomes

  1. Baseline demographics and clinical characteristics of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.

    Time frame: from the 1st August 2020 to 30th September 2024

  2. Baseline laboratory measures (number of measures per year and their values) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.

    Time frame: from the 1st August 2020 to 30th September 2024

  3. Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.

    Time frame: Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.

  4. Initiation of kidney-protective treatment (RAASi or SGLT2i or both) among treatment naïve patients in the pre-P&R cohort and post- P&R

    Time frame: from the 1st August 2020 to 30th September 2024

  5. Discontinuation of newly initiated RAASi or SGLT-2i treatment in the two cohorts of the study, pre-P&R and post-P&R cohorts

    Time frame: from the 1st August 2020 to 30th September 2024

  6. Discontinuation of ongoing RAASi and/or SGLT-2i treatment among treated patients (proportion of patients, time to discontinuation) in the two cohorts of the study, pre-P&R and post-P&R cohorts.

    Time frame: from the 1st August 2020 to 30th September 2024

Secondary outcomes

  1. To describe the current clinical landscape among incident renal disease/incident CKD patients and in new initiators of kidney protective treatment- patients during the follow-up period

    Time frame: from the 1st August 2020 to 30th September 2024

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multinational, Observational, Retrospective, Secondary Data Study Describing Management and Treatment in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Oct 10, 2025

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.

Published trials that share one or more normalized conditions with this study.