Phase 4
Completed N=20
Desensitization in Kidney Transplantation
HLA Sensitization
Source: ClinicalTrials.gov NCT00908583 ↗
Enrolled (actual)
20
Serious AEs
28.8%
Results posted
Feb 2016
Primary outcomePrimary: Number of Living Donor Transplant Candidates That Are Transplanted — 19 participants
Summary
To determine if deletional strategies will provide effective desensitization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Living Donor Transplant Candidates That Are Transplanted |
19 | — |
| SECONDARY Overall Safety of Bortezomib |
1; 2; 1; 0; 0; 0 | — |
| SECONDARY Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50% |
6 | — |
| SECONDARY Acute Rejection Rate |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 65
- Voluntary written informed consent
- Patient on deceased donor wait list with a current or peak cytotoxic or calculated panel reactive antibody (PRA) > 20%
Exclusion Criteria
- Myocardial infarction within 6 months
- Patient received investigational drug within 14 days prior to initiation of study treatment
- Serious medical or psychological illness
- Diagnosed with malignancy within three years, except complete research of basal cell carcinoma or squamous cell carcinoma of skin, an insitu malignancy or low risk prostate cancer after curative therapy
- Absolute neutrophil count (ANC) < 1000
- Receipt of live vaccine within 4 weeks of study entry
- Female subject that is breast feeding
Data sourced from ClinicalTrials.gov (NCT00908583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.