National Unified Renal Translation Research Enterprise - Chronic Kidney Disease
brief summary
Chronic Kidney Disease (CKD) affects around 10% of the adult population and is associated with an increased risk of heart attack, stroke and end stage kidney disease (ESKD). This study aims to better predict who is most likely to progress to ESKD using previously identified risk factors and novel biomarkers in blood and urine samples, along with kidney biopsy tissue. Resources can then be directed to those most at risk of disease progression and other associated conditions such as heart attack and stroke, while those at lower risk can be offered less frequent monitoring.
detailed description
3,000 participants will be recruited from nephrology clinics at multiple participating centres (planned to start with 11). 100 control participants (without CKD) will be recruited from among hospital staff members, people attending diabetes clinics and the general public via advertisements placed in the hospitals and in the press.
Study participants with CKD will participate in the study for 12 - 18 months of active follow-up. After that participants will be sent a questionnaire annually by post to assess quality of life (EQ-5D-5L) and health care resource utilisation during the previous year and the investigators will collect outcome data without the need for further study visits; this annual follow-up by questionnaire will continue for 14 years following their second study visit.
Study participants acting as normal controls will attend only a single study visit.
All participants will provide written informed consent prior to undergoing any interventions. After providing written informed consent participants will undergo the following assessments and study procedures:
Medical History: The following data will be collected by interview, questionnaire and examination of the participants' medical records.
* Socio-demographic: age, gender, ethnicity, first language, education status, marital status, employment, indices of multiple deprivation (IMD) score (derived from postcode of residence), smoking history, alcohol intake, dietary status (vegetarian/vegan) * Medical: All previous illnesses with particular focus on CKD diagnosis, previous AKI, hypertension, diabetes, cardiovascular disease (CVD), atrial fibrillation, rheumatoid arthritis, thyroid disease, retinopathy (if diabetic), peripheral neuropathy (if diabetic). These will be used to calculate the Charleston Comorbidity Index. * Family medical history: CVD before age 60 years, diabetes, CKD, ESKD. * All current medication including over the counter preparations and supplements/herbal preparations. * Vaccination status for influenza and pneumococcus * Prior laboratory results, especially prior serum creatinine results to enable analysis of trend in eGFR. * The above data will be recorded on a questionnaire that participants will be asked to complete at or prior to the baseline study visit. Questionnaires will be checked by research staff at the study visit and participants will be assisted in completing the questionnaires if required. Details of the medical history and blood results will be verified by inspection of participants' hospital medical records.Quality of Life and Functional Status * Quality of life will be measured by EQ-5D-5L quality of life questionnaire * Functional status will assessed using the Karnofsky score * Current symptoms will be assessed using an Palliative Outcome Scale (POS) questionnaire (POS-Renal P7) * Health literacy will be assessed by questionnaire (single question SILS) * Cognitive function will be assessed with the "six item Cognitive Impairment Test" (6CIT) questionnaire * Anxiety and depression symptoms will be assessed with the "Hospital Anxiety and Depression Scale" (HADS)