Chronic Kidney Disease - Renal Epidemiology and Information Network (CKD-REIN)

October 9, 2019 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Chronic Kidney Disease - Renal Epidemiology and Information Network: The CKD-REIN Cohort

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

3033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with CKD Stage 3-5 (eGFR <60 ml/min/1.73m2, not on dialysis or with kidney transplant) receiving nephrology care

Description

Inclusion Criteria:

  • eGFR < 60 ml/min/1.73m2 for at least 1 month
  • no prior chronic dialysis or transplantation
  • Written Signed consent form

Exclusion Criteria:

  • Age <18 yrs old,
  • Pregnant female,
  • patients who plan to move
  • Unable to give inform consent,
  • Decline to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of end-stage renal disease (ESRD)
Time Frame: up to 5 years
Dialysis, transplantation, conservative care management
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: up to 5 years
Specific and all-cause mortality
up to 5 years
Incidence of major CKD events including acute kidney injury, cardiovascular and metabolic complications
Time Frame: up to 5 years
up to 5 years
Incidence of major adverse events including infections, cancer, mineral and bone disease, anemia, nutitional status, hospitalizations
Time Frame: up to 5 years
up to 5 years
Prescription drug use
Time Frame: 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.
up to 5 years
Health-related Quality of life
Time Frame: 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.
up to 5 years
Depression
Time Frame: 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.
up to 5 years
Cognitive function
Time Frame: 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.
up to 5 years
Physical Activity
Time Frame: 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.
up to 5 years
Family relationships
Time Frame: 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.
up to 5 years
Sleep disorders
Time Frame: up to 5 years
up to 5 years
Women's health
Time Frame: up to 5 years
Set of questions regarding the menopause, menstrual cycle and contraception, and past/in progress pregnancies.
up to 5 years
Cost effectiveness of different treatment practices and services
Time Frame: 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).
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Central Hospital, Nancy, France
University Hospital, Bordeaux
Etablissement Français du Sang
Centre Hospitalier Lyon Sud
Agence de La Biomédecine
Amiens University Hospital
Arbor Research Collaborative for Health
Hospital Ambroise Paré Paris
Université Paris-Sud
Institut de Formation et de Recherche sur les Organisations Sanitaires et Sociales
Biobanque de Picardie
Centre National de Génotypage
Institut des Maladies Métaboliques et Cardiovasculaires

Investigators

  • Principal Investigator: Bénédicte Stengel, MD, Inserm U1018, UPS-UVSQ, CESP, Renal and Cardiovascular Epidemiology team, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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