Chronic Kidney Disease - Renal Epidemiology and Information Network

NCT03381950 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3033

Last updated 2019-10-11

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency, Chronic

Sponsors & Collaborators

  • Université Paris-Sud

    collaborator OTHER
  • Agence de La Biomédecine

    collaborator OTHER_GOV
  • Arbor Research Collaborative for Health

    collaborator OTHER
  • Hospital Ambroise Paré Paris

    collaborator OTHER
  • Centre Hospitalier Lyon Sud

    collaborator OTHER
  • Central Hospital, Nancy, France

    collaborator OTHER
  • Institut de Formation et de Recherche sur les Organisations Sanitaires et Sociales

    collaborator UNKNOWN
  • Biobanque de Picardie

    collaborator UNKNOWN
  • Centre National de Génotypage

    collaborator OTHER
  • Institut des Maladies Métaboliques et Cardiovasculaires

    collaborator UNKNOWN
  • Etablissement Français du Sang

    collaborator OTHER
  • Amiens University Hospital

    collaborator OTHER
  • University Hospital, Bordeaux

    collaborator OTHER
  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2021-07-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381950 on ClinicalTrials.gov