French Renal Epidemiology and Information Network (REIN) Registry (REIN-LOR)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03967808|
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : June 5, 2019
|Condition or disease|
|End-stage Renal Disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6000 participants|
|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|
- 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
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
|Contact: Carole Ayav, MDemail@example.com|
|Contact: Francis Guillemin, MD,PhDfirstname.lastname@example.org|
|Nephrology unit, University hospital||Recruiting|
|Nancy, France, 54000|
|Contact: Emmanuelle Laurain, MD email@example.com|
|Principal Investigator:||Emmanuelle Laurain, MD||Central Hospital, Nancy, France|