EVEROLD LONG TERM FOLLOW-UP

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

Long Term Follow up of EVEROLD study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed patients participating to the EVEROLD study

Patient having completed the EVEROLD M12 follow-up visit

Patient agreeing to participate in the observational study

Disqualifiers

Opposition to the use his medical data

Patient under legal protection

Trial population

260 patients previously included in the EVEROLD study

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

260 Participants
are grouped into 3 trial groups
Group A: Active Comparator: Control
Group B: Experimental: CNI-free
Group C: Experimental: Switch

Trial outcomes

Primary outcomes

1

Patient survival

Patient survival at last follow-up

Time frame
up to 12 years
2

Graft survival

Graft survival at last follow-up

Time frame
up to 12 years

Secondary outcomes

1

Rejection rate

Biopsy proven rejection

Time frame
up to 12 years
2

Infection rate

All infections requiring hospitalization

Time frame
up to 12 years
3

Major cardiovascular events

Time frame
up to 12 years
4

Cancer rate

Skin cancer, solid organ tumor and hematological cancer

Time frame
up to 12 years

Other outcomes

Sponsors and contacts

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