Bio-ADM as a Biomarker of Refilling in Chronic Hemodialys... | NCT05339009

Studies
Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient

NCT05339009

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease 5D

Interventions

BioADM determination in plasma

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

Apr 2022

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

Apr 1, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

May 1, 2023Estimated

First Submitted Date

Apr 13, 2022

First Submission Date that Met QC Criteria

Apr 13, 2022

First Posted Date

Apr 21, 2022Actual

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

Apr 13, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All patients receive conventional dialysis treatment at inclusion		All patients receive conventional dialysis treatment at inclusion	Biological: BioADM determination in plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioADM determination in plasma	Biological	BioADM determination in plasma	All patients receive conventional dialysis treatment at inclusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationship between bio-ADM level and vascular refilling rate	The refilling rate will be assessed by the ratio of relative blood volume and UF max	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Bio-ADM value according to comorbidity factors	Bio-ADM value according to comorbidity factors (diabetes, heart failure and low-grade inflammation)	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
Anuric patient

Exclusion criteria:

Patient protected by law
Patient under guardianship ou curatorship
Patient deprived of liberty

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients issued from dialysis units (non profit dialysis centers)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Paul CRISTOL, MD PhD	Contact	+33 467 338315		jp-cristol@chu-montpellier.fr
Marion MORENA CARRERE, PhD	Contact	+33 411 759893		m-morenacarrere@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Jean-Paul CRISTOL, MD PhD	University Hospital Center of Montpellier, FRANCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH Montpellier	Recruiting	Montpellier			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