Clinical Impact of the IBox As an Early Intervention TooL

Condition(s) studied

Investigational drug(s) / intervention(s)

Predigraft: The Subject randomized to the Predigraft will benefit from Predigraft, a remote monitoring software that issues an alert to the investigator when the allograft survival prediction calculated by the iBox algorithm is decreasing. This follow-up is on top of the site's standard of care.

Study summary

International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.

Eligibility

Primary outcome measure(s)

• number of biopsies leading to therapeutic change — 18 months
  number of biopsies leading to therapeutic change by the end of the follow-up (18 months).

Trial sites (16)

Other trials for the same condition