NCT05388409

Brief Summary

To look for the factors of exposure present prior to the onset of Porto-Sinusoidal Vascular Disease (PSVD) and which can lead to the occurrence of PSVD after renal transplantation, and therefore to consider the identification of risk factors, in order to prevent or detect early signs of portal hypertention in predisposed patients and improve their prognosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 25, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 26, 2025

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

April 29, 2022

Last Update Submit

March 24, 2025

Conditions

Porto-Sinusoidal Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • To highlight risk factors significantly related to the occurrence of PSVD in renal transplant recipients.

    Blood samples histrory results analyse to identify usual prothrombic factors associated (or not) to PSVD (e.g;, myeloproliferative syndrome, Factor V Leiden mutation, blood group, ...).

    2 years

Secondary Outcomes (3)

  • Clinical profiles.

    2 years

  • Biological, and evolutionary profiles.

    2 years

  • Evolution of liver function.

    2 years

Study Arms (3)

CASE

Kidney transplanted patients with PSVD

Control 1

Kidney transplanted patients without PSVD

Control 2

patient with PVSD without transplantation

Eligibility Criteria

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

CASE : PSVD after kidney transplantation. Controls : Kidney transplantation without PSVD and PSVD without kidney transplantation.

You may qualify if:

  • PSVD (between january 2000 and december 2021) after kidney transplantation or
  • Kidney transplantation without PSVD or
  • PSVD without kidney transplantation

You may not qualify if:

  • liver cirrhosis
  • transplanted from an other organ
  • thrombocytopenia and/or abnormal liver tests and/or hepatic dysmorphism and/or portal hypertension signs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Caen

Caen, Calvados, 14033, France

Location

MeSH Terms

Conditions

Idiopathic Noncirrhotic Portal Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PortalLiver DiseasesDigestive System Diseases

Study Design

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

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 24, 2022

Study Start

October 25, 2021

Primary Completion

February 7, 2023

Study Completion

December 30, 2023

Last Updated

March 26, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)