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French Renal Epidemiology and Information Network (REIN) Registry (REIN-LOR)

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ClinicalTrials.gov Identifier: NCT03967808
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Agence de La Biomédecine
Information provided by (Responsible Party):
Carole AYAV, Central Hospital, Nancy, France

Brief Summary:
The Renal Epidemiology and Information Network (REIN) Registry was created in 2002 (after study pilot in 2001) to contribute to the development and evaluation of health strategies aiming at improving prevention and management of end-stage renal disease, and promoting clinical and epidemiological research in this field. It relies on a network of nephrologists, epidemiologists, patients and public health representatives, coordinated regionally and nationally.

Condition or disease
End-stage Renal Disease

Detailed Description:

The REIN registry is intended to include all end stage renal disease patients on renal replacement therapy (RRT) - either dialysis or transplantation - living in Lorraine area.

New (incident) patients are reported from the first day of RRT. Patients with a diagnosis of acute renal failure are excluded, i.e. those who recover all or some renal function within 45 days or are considered as such by experts when they die before 45 days. Patients with pre-emptive grafts and those living with a functioning graft are identified from the transplant database.

A set of basic items, including fixed and annually updateable items, was defined for all dialysis patients. Five types of events are reported to the registry on occurrence from the first day of any treatment: (1) renal transplantation, (2) changes in dialysis setting, (3) changes in type of dialysis, (4) transient recovery of renal function and (5) death.

The participation rate of centres in Lorraine is 100%. A clinical research assistant visits every dialysis centre to verify the completeness of patient and event registration, by comparing reports to the registry with centre administration files.

The REIN guide defines all items to be recorded, includes coding instructions, and serves as a standard for all participating regions.

REIN consists of a partnership network and professionals whose Biomedicine Agency is the institutional support. The National level consists of a national coordination, a steering group and a scientific board. Regional level includes a Regional Steering Group led by nephrologist and epidemiological coordinators and an epidemiological unit.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: French Renal Epidemiology and Information Network (REIN) Registry in Lorraine
Actual Study Start Date : January 2001
Estimated Primary Completion Date : December 2050
Estimated Study Completion Date : December 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure




Primary Outcome Measures :
  1. Occurence of end stage renal disease in Renal Replacement therapy [ Time Frame: One year ]
    New (incident) patients are reported from the first day of Renal Replacement Therapy - either dialysis or renal transplantation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All new patients reaching end-stage chronic renal failure and requiring support by a renal replacement therapy
Criteria

Inclusion Criteria:

  • All patients with end stage renal disease on renal replacement therapy

Exclusion Criteria:

  • Patients with acute renal failure ( i.e. those who recover all or some renal function within 45 days or are considered as such by experts when they die before 45 days)
  • Patient's refusal

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): NCT03967808


Contacts
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Contact: Carole Ayav, MD c.ayav@chru-nancy.fr
Contact: Francis Guillemin, MD,PhD francis.guillemin@chru-nancy.fr

Locations
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France
Nephrology unit, University hospital Recruiting
Nancy, France, 54000
Contact: Emmanuelle Laurain, MD       e.laurain@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Agence de La Biomédecine
Investigators
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Principal Investigator: Emmanuelle Laurain, MD Central Hospital, Nancy, France

Publications:
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Responsible Party: Carole AYAV, Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03967808     History of Changes
Other Study ID Numbers: REIN-01
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Open to partnership
Keywords provided by Carole AYAV, Central Hospital, Nancy, France:
Registry
Renal replacement therapy
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency