NCT05527626

Brief Summary

Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry). Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage. Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Feb 2022Aug 2027

Study Start

First participant enrolled

February 17, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

5.5 years

First QC Date

August 30, 2022

Last Update Submit

November 7, 2023

Conditions

Keywords

KidneyChronic DiseaseChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Retroanalysis of the risk factors in patients with severe chronic kidney disease

    Analysis of risk factors in patients with severe chronic kidney disease by retrospectively analyzing health data contained in patient medical records

    Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject (≥18 years) with a chronic renal disease

You may qualify if:

  • Major subject (≥18 years)
  • Subject included in the MRC package (GFR \<30 ml/min/1.73 m2)
  • Subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research

You may not qualify if:

  • \- Subject having expressed his opposition to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicChronic Disease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peggy PERRIN, MD

    Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 2, 2022

Study Start

February 17, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations