Registry for End Stage Renal Failure | NCT02895425

Studies
Registry for End Stage Renal Failure

NCT02895425

Sponsor

Centre Hospitalier de Cayenne

Status

Unknown status

Last Update Posted

Sep 9, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

End Stage Renal Failure

Interventions

Registry (No intervention)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2021Estimated

First Submitted Date

Sep 6, 2016

First Submission Date that Met QC Criteria

Sep 8, 2016

First Posted Date

Sep 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2016

Last Update Posted Date

Sep 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The rein registry collects case record data from patients with end stage renal disease followed in French Guiana. This allows to generate incidence and rates for terminal renal disease, mortality rates for each territory. The regional data are pooled in order to get national statistics for end stage renal disease and transplantation activity in order to adapt prevention to the main causes of renal failure and treatment and care infrastructure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Registry (No intervention)	Other

Measure	Description	Time Frame
Death		10 years
Transplant		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

End Stage Renal Failure

Exclusion Criteria:

Refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient with End Stage Renal Failure followed in one of the dialisys sites in frnech Guiana

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Cayenne	Recruiting	Cayenne	French Guiana	97306	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012042	Registries

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D011996	Records

Browse Leaves

Not provided

Browse Branches

Not provided