End-stage Renal DiseaseREIN-LORNCT03967808
French Renal Epidemiology and Information Network (REIN) Registry
An observational study of End-stage Renal Disease, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-stage Renal Disease
- How many people
- 6,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2001to Dec 2050
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All new patients reaching end-stage chronic renal failure and requiring support by a renal replacement therapy
Who may be able to join
- All patients with end stage renal disease on renal replacement therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carole Ayav, MD contact
Francis Guillemin, MD,PhD contact
France1 site, 1 recruiting
- Recruiting
Nephrology unit, University hospital
Nancy, 54000
Emmanuelle Laurain, MD, e.laurain@chru-nancy.fr
About this study
Official title: French Renal Epidemiology and Information Network (REIN) Registry in Lorraine
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Keywords
- Registry, Renal replacement therapy
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study startJan 2001
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Principal investigator, Carole AYAV, Central Hospital, Nancy, France
- Investigators
- Emmanuelle Laurain, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967808
- Sponsor's protocol ID
- REIN-01
- Acronym
- REIN-LOR
- Status last verified
- Jul 2021
- First submitted
- 27 May 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Open to partnership
Publications
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.
PubMed 25457107Couchoud 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. doi: 10.1093/ndt/gfi198. Epub 2005 Oct 18.
PubMed 16234286
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Renal Epidemiology and Information Network (REIN) Registry in Lorraine
- ClinicalTrials.gov ID
- NCT03967808
- Acronym / sponsor ID
- REIN-LOR / REIN-01
- Conditions
- End-stage Renal Disease
- Keywords
- Registry, Renal replacement therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- Jan 2001 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All new patients reaching end-stage chronic renal failure and requiring support by a renal replacement therapy
Key inclusion criteria (1 listed)
- All patients with end stage renal disease on renal replacement therapy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 25457107Lassalle 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.
- Background: PubMed 16234286Couchoud 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. doi: 10.1093/ndt/gfi198. Epub 2005 Oct 18.
- Individual participant dataSharing planned: Undecided. Open to partnership
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carole Ayav, MD contact
Francis Guillemin, MD,PhD contact
Emmanuelle Laurain, MD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carole Ayav, MD (c.ayav@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of end stage renal disease in Renal Replacement therapy (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.