NCT02843295

Brief Summary

Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

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

September 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

July 21, 2016

Last Update Submit

August 24, 2016

Conditions

Renal Transplantation

Keywords

renal transplantationimmunologyrejection

Outcome Measures

Primary Outcomes (6)

  • PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)

    at 3 months post-transplantation

  • PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)

    at 6 months post-transplantation

  • PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)

    at 9 months post-transplantation

  • PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)

    at 12 months post-transplantation

  • PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)

    at 18 months post-transplantation

  • PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)

    at 24 months post-transplantation

Secondary Outcomes (15)

  • Glomerular filtration rate by MDRD formula (ml/min)

    at 3 months post-transplantation

  • Glomerular filtration rate by MDRD formula (ml/min)

    at 6 months post-transplantation

  • Glomerular filtration rate by MDRD formula (ml/min)

    at 9 months post-transplantation

  • Glomerular filtration rate by MDRD formula (ml/min)

    at 12 months post-transplantation

  • Glomerular filtration rate by MDRD formula (ml/min)

    at 18 months post-transplantation

  • +10 more secondary outcomes

Study Arms (1)

Population of the study

EXPERIMENTAL

3 stratification groups: Group 1: High immunologic risk Patients receiving a ≥ 2nd graft and/or Panel Reactive Antibody ≥ 30% and/or Human Leukocyte Antigen (HLA) mismatches ≥ 4 Group 2: High non-immunologic risk Donors over 60 years of age and/or Donor between 50 to 59 years of age who have died of stroke, or had a history of high blood pressure, or at the time of death had a creatininemia ≥ 135 µmol/L Group 3: Low risk Patients not included in Groups 1 or 2

Other: blood samples

Interventions

blood samplesOTHER
Population of the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 the day of transplantation
  • Recipient of a renal graft
  • Informed consent to participate to the study
  • Patient transplanted and followed 2 years in one of the 3 transplantation centers of the study (Hospital Edouard Herriot or Centre Hospitalier Lyon Sud)

You may not qualify if:

  • Multiorgan transplantation
  • Previous transplantation
  • ABO incompatible renal transplantation
  • Patient \> 18 years old but under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transplantation Department

Lyon, 69003, France

Location

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olivier THAUNAT, MD

    Hospices Civils de Lyon - Transplantation Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 25, 2016

Study Start

September 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)