Chronic Kidney Disease - Renal Epidemiology and Information Network
- Conditions
- Renal Insufficiency, Chronic
- Registration Number
- NCT03381950
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Brief Summary
Preserving kidney function and improving the transition from CKD to End stage renal disease (ESRD) is a research and healthcare challenge. The Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort was established to identify the determinants, biomarkers and practice patterns associated with chronic kidney disease outcomes. The study includes 3,033 adult patients with moderate to advanced CKD from a representative sample of 40 nephrology clinics in France with respect to regions and legal status. Patients are recruited during a routine visit and followed up for 5 years, before and after starting renal replacement therapy. Patient-level clinical, biological, and lifestyle data are collected annually, as well as provider-level data on clinical practices, coordinated with the International Chronic Kidney Disease Outcomes and Practice Pattern Study (CKDopps). Blood and urine samples are stored in a biobank. The overall objective is to develop a research platform to address key questions regarding the determinants and biomarkers associated with adverse outcomes in CKD and to assess its effective management. It has the following hypotheses and specific aims:
1. to evaluate a large set of social, environmental, bioclinical, and genetic factors, and their interactions in relation with CKD outcomes including progression to ESRD, mortality, metabolic and vascular complications, and the onset of a number of chronic and acute events;
2. to assess several new biomarkers to predict adverse outcomes of CKD and its complications;
3. to evaluate the associations of provider practices (management of hypertension, anemia, nutritional abnormalities, mineral and bone disorder, nutritional status, timing of dialysis initiation and transplant wait-listing) with achievement of clinical practice guidelines, clinical and patient-reported outcomes (PRO).
4. to evaluate the associations of health care organization and clinic services (e.g., for nutrition, educational programs) with clinical and patient-reported outcomes, and achievement of clinical practice guidelines;
5. to estimate the relative cost-effectiveness of different provider practices and clinic services.
- Detailed Description
All cohort participants are assessed annually for at least 5 years, until 6 months after the start of renal replacement therapy.
Each year, data are collected from both medical records and patients interview and self-administrated questionnaires are asked to report clinical events.
Interviews and routine biological measurements are repeated annually.
CKD-REIN is funded by the Agence Nationale de la Recherche through the 2010 'Cohortes-Investissements d'Avenir' programme and by the 2010 national Programme Hospitalier de Recherche Clinique.
CKD-REIN is also supported through a public-private partnership with Amgen, Fresenius Medical Care, and GlaxoSmithKline since 2012; Baxter and MerckSharp\&Dohme-Chibret (France) from 2012 to 2017; LillyFrance since 2013; Otsuka Pharmaceutical since 2015; Vifor Fresenius since 2017; AstraZeneca since 2018; and Sanofi-Genzyme from 2012 to 2015.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3033
- eGFR < 60 ml/min/1.73m2 for at least 1 month
- no prior chronic dialysis or transplantation
- Written Signed consent form
- Age <18 yrs old,
- Pregnant female,
- patients who plan to move
- Unable to give inform consent,
- Decline to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of end-stage renal disease (ESRD) up to 5 years Dialysis, transplantation, conservative care management
- Secondary Outcome Measures
Name Time Method Depression up to 5 years Assessed by the 10-item Center for Epidemiologic Studies Depression Scale (CESD). It is a screening test for depression and depressive disorder. A total score is reported.The possible range is 0 to 30, with the higher scores indicating more depression symptoms.
Cognitive function up to 5 years The 30-item minimental status examination (MMSE) is a practical tool for evaluating cognitive status. A total score is reported, ranged from 0 to 30, with the higher scores indicating less cognitive impairment.
Incidence of major CKD events including acute kidney injury, cardiovascular and metabolic complications up to 5 years Incidence of major adverse events including infections, cancer, mineral and bone disease, anemia, nutitional status, hospitalizations up to 5 years Women's health up to 5 years Set of questions regarding the menopause, menstrual cycle and contraception, and past/in progress pregnancies.
Cost effectiveness of different treatment practices and services up to 5 years Several data sources will be used to estimate the cost of different treatment practices and services.
Patient-Level: key resource utilization indicators (e.g., hospitalization, clinic visits, prescription drug use), and procedures for costing these measures.
Clinic-level: The net costs of different treatment practices as well as structural characteristics (such as number of beds of the hospital, number of wards, number of hierarchical levels, for-profit or non for-profit status, teaching or not teaching hospital, spatial organization).Health-related Quality of life up to 5 years Assessed by the Kidney Disease Quality of Life (KDQOL™) scale. It is a measure of kidney disease-related quality of life that comprises four subscales: Generic core \[Physical Component Summary (PCS) and Mental Component Summary (MCS)\]; Symptoms/Problems; Burden of Kidney Disease, and Effects of Kidney Disease. Scores of each subscale are calculated, ranged from 0 to 100, with higher scores reflecting better quality of life.
Physical Activity up to 5 years The French translation of the Global Physical Activity Questionnaire (Version 2.0) is used to gather information on the time spent in moderate and vigorous physical activity and in sedentary behavior. The GPAQ contains 16 items designed to assess the frequency and duration of physical activity in 3 domains: during work, transportation, and leisure time as well as time spent sitting during a typical week. It distinguishes physical activity duration by min/day and min/week for each physical activity domain, which allows for calculating the energy expenditure scored in metabolic equivalent tasks (METs). According to duration and energy expenditure, physical activity level was classified as low, moderate, and high.
Family relationships up to 5 years Assessed by the Family Relationships Index (FRI). the FRI provides a brief measure of family relations by assessing the way people currently perceive and describe their family. The scale consists of 12 items. Each item is coded from 1 to 4. A validation study of this questionnaire is planned.
Prescription drug use up to 5 years For each drug prescription, the trade name, international non-proprietary name, ATC class, unit dose, defined daily dose, pharmaceutical formulation, and administration route are recorded. A linkage with the drug reimbursement files from the health insurance will be also performed.
Sleep disorders up to 5 years Mortality up to 5 years Specific and all-cause mortality