French Renal Epidemiology and Information Network (REIN) Registry

End-stage Renal Disease Clinical Trial

— REIN-LOR  

Official title:

French Renal Epidemiology and Information Network (REIN) Registry in Lorraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03967808
• Other study ID #: REIN-01
• Status: Recruiting
• Start date: January 2001
• Est. completion date: December 2050

Study information

• Verified date: July 2021
• Source: Central Hospital, Nancy, France
• Contact: Carole Ayav, MD
• Email: c.ayav[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2050
• Est. primary completion date: December 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Locations

Country	Name	City	State
France	Nephrology unit, University hospital	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Agence de La Biomédecine

Country where clinical trial is conducted

France, 

References & Publications (2)

Couchoud C, Stengel B, Landais P, Aldigier JC, de Cornelissen F, Dabot C, Maheut H, Joyeux V, Kessler M, Labeeuw M, Isnard H, Jacquelinet C. The renal epidemiology and information network (REIN): a new registry for end-stage renal disease in France. Nephrol Dial Transplant. 2006 Feb;21(2):411-8. Epub 2005 Oct 18. — View Citation

Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of end stage renal disease in Renal Replacement therapy	New (incident) patients are reported from the first day of Renal Replacement Therapy - either dialysis or renal transplantation	One year