Reduced-dose Alemtuzumab for Kidney Transplant Rejection
ConditionKidney Transplant Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.
Disqualifiers
Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode.
Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies).
Inability to provide written informed consent
Trial population
Kidney transplant recipients who experience severe or glucocorticoid-resistant rejection of their allograft.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of patients with lymphocyte repopulation
Outcome reporting of the proportion of patients that has repopulation of T and B lymphocytes, defined as cell counts of \>200 10E6/L for T lymphocytes and \> 100 10E6/L for B lymphocytes.
Time frame
6 months and 1 yearSecondary outcomes
1
Cumulative incidence of graft loss
Cumulative incidence of graft loss at specified time-points with death as competing risk, computed by cumulative incidence functions.
Time frame
6 months, 1 year2
Serious infections
Necessitating hospital admission, or hospital-acquired
Time frame
6 months, 1 year3
Patient survival
Proportion of patients who survived at specified time-points, computed with kaplan-meier estimates at specified time-points.
Time frame
6 months, 1 yearSponsors and contacts
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Source ClinicalTrials.gov