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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381950
Recruitment Status : Active, not recruiting
First Posted : December 22, 2017
Last Update Posted : October 11, 2019
Sponsor:
Collaborators:
Université Paris-Sud
Agence de La Biomédecine
Arbor Research Collaborative for Health
Hospital Ambroise Paré Paris
Centre Hospitalier Lyon Sud
Nancy University Hospital
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
Etablissement Français du Sang
Amiens University Hospital
University Hospital, Bordeaux
Information provided by (Responsible Party):
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.

Condition or disease
Renal Insufficiency, Chronic

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.

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Study Type : Observational
Actual Enrollment : 3033 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Kidney Disease - Renal Epidemiology and Information Network: The CKD-REIN Cohort
Actual Study Start Date : July 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of end-stage renal disease (ESRD) [ Time Frame: up to 5 years ]
    Dialysis, transplantation, conservative care management


Secondary Outcome Measures :
  1. Mortality [ Time Frame: up to 5 years ]
    Specific and all-cause mortality

  2. Incidence of major CKD events including acute kidney injury, cardiovascular and metabolic complications [ Time Frame: up to 5 years ]
  3. Incidence of major adverse events including infections, cancer, mineral and bone disease, anemia, nutitional status, hospitalizations [ Time Frame: up to 5 years ]
  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Sleep disorders [ Time Frame: up to 5 years ]
  11. Women's health [ Time Frame: up to 5 years ]
    Set of questions regarding the menopause, menstrual cycle and contraception, and past/in progress pregnancies.

  12. 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).



Biospecimen Retention:   Samples With DNA
Serum, plasma and urine samples are collected and stored on all patients at enrollment and study end, and in a subsample of 1,200 at 2-year follow-up.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381950


Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Université Paris-Sud
Agence de La Biomédecine
Arbor Research Collaborative for Health
Hospital Ambroise Paré Paris
Centre Hospitalier Lyon Sud
Nancy University Hospital
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
Etablissement Français du Sang
Amiens University Hospital
University Hospital, Bordeaux
Investigators
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Principal Investigator: Bénédicte Stengel, MD Inserm U1018, UPS-UVSQ, CESP, Renal and Cardiovascular Epidemiology team, Paris, France
Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03381950    
Other Study ID Numbers: C12-30
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
chronic kidney disease
prospective cohort study
risk profile
patient-reported-outcomes
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases