Kidney disease is an important and serious problem both in patients with and without type 2 diabetes. In a time of emerging treatment options that may offer benefits to patients with chronic kidney disease, there is an increasing need to understand the size of the problem, characteristics of patients affected and the impact of the choice of medications used to treat these patients in clinical practice. The results from recently concluded clinical trials are very encouraging and show the treatment reduced the progression of kidney deterioration in patients with and without diabetes who already have established chronic kidney disease. However, as only limited number of people can be enrolled in trials due to the rigorous selection criteria, the findings may not be generalised across all populations. There are very few contemporary reports on the characteristics and outcomes of kidney disease that have investigated specific subgroup populations, particularly people who may be at a higher risk of experiencing kidney diseases. In addition, the role of new therapies that may offer benefits to patients with chronic kidney disease is yet to be explored, including how the disease progression may increase risks of complications, death and healthcare cost in these patients. Therefore, this study will use administrative healthcare records to describe populations of patients with kidney disease in order to understand the disease burden and their association with worse clinical outcomes and death.
Using a cohort of patients with kidney diseases, we will describe and compare the characteristics of chronic kidney disease (CKD) patients, patterns of disease progression and adverse complications over time, including the epidemiology of kidney disease in various subgroup populations.
This study will utilise routinely collected primary care and secondary care records of patients to investigate clinical outcomes. The main outcomes of interest include all-cause death (including cardiovascular or renal deaths), reduction in estimated glomerular filtration rate (eGFR) or urine:albumin creatinine ratio (UACR), specific hospitalisations for heart failure, myocardial infarction, stroke, peripheral artery disease, hyperkalaemia, and renal outcomes (acute and chronic kidney diseases, end-stage renal disease and dialysis).
The study will assess multiple subgroups of patients in both the descriptive analysis as well as the follow-up study design. Subgroups of interest include patients with or without type 2 diabetes mellitus, patients at different diagnostic clinical assessments of renal function (e.g., eGFR stages, uACR bands), patients with and without standard treatments for kidney disease, cardiovascular disease and diabetes mellitus. The study will also investigate outcomes in a subgroup of patients defined by clinical trial criteria described in the study population section.
The study period will begin on 1 January 2007 until the last GP’s collection date. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Survival distributions utilising Kaplan-Meir method will describe the time to clinical outcomes. Relative risks and risk factors associated with outcomes will be estimated using Cox proportional hazard models.
In addition, we aim to further evaluate the care pathways of the patients to describe health resource use including GP consultations, laboratory tests or measurements, medication, referrals to specialist and hospital admissions. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
The study outcomes are aligned to the core objectives of this study and described below.
Primary outcomes include composite and individual components of specific hospitalisations for heart failure (HF), myocardial infarction (MI), stroke, peripheral artery disease (PAD), renal outcomes (including renal function decline, hospitalisation for kidney diseases, end-stage renal disease [ESRD] and dialysis), cardiovascular and all-cause death, and their associated risk factors.
Secondary outcomes include monetised costs of health care resource use; resources include disease management services in the clinical guideline, e.g., GP consultations, laboratory tests, medications and hospitalisations. Others include urgent care visits, emergency department attendances, and dialysis.
Jil Billy Mamza - Chief Investigator - AstraZeneca Ltd - UK Headquarters
He Gao - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Alexander Gueret-Wardle - Collaborator - AstraZeneca Ltd - UK Headquarters
Bhautesh Jani - Collaborator - University of Glasgow
Emily Peach - Collaborator - AstraZeneca Ltd - UK Headquarters
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
James Chess - Collaborator - SWANSEA BAY UNIVERSITY HEALTH BOARD
Jiji Nair - Collaborator - Astra Zeneca Inc - USA
Jun Zou - Collaborator - Astra Zeneca Inc - USA
Manish Tripathi - Collaborator - Astra Zeneca Inc - USA
Matthew Arnold - Collaborator - AstraZeneca Ltd - UK Headquarters
Naresh Kanumilli - Collaborator - NHS England
Navdeep Tangri - Collaborator - University of Manitoba
Nicola Milne - Collaborator - Manchester University NHS Foundation Trust (MFT)
Patrick Mark - Collaborator - University of Glasgow
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK Headquarters
Salvatore Barone - Collaborator - Astra Zeneca Inc - USA
Senthil Periaswamy - Collaborator - Astra Zeneca Inc - USA
Smeeta Sinha - Collaborator - Salford Royal Hospital NHS Foundation
Tamsin Morris - Collaborator - AstraZeneca Ltd - UK Headquarters
Xiaojian Chen - Collaborator - Astra Zeneca Inc - USA
Mina Khezrian - Collaborator - AstraZeneca Ltd - UK Headquarters
Supriya Kumar - Collaborator - AstraZeneca Ltd - UK Headquarters
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation