Phase 4 N=20 Treatment

Desensitization in Kidney Transplantation

HLA Sensitization

Bottom Line

View on ClinicalTrials.gov: NCT00908583 ↗

Enrolled (actual)

Serious AEs

28.8%

Results posted

Feb 2016

Primary outcome: Primary: Number of Living Donor Transplant Candidates That Are Transplanted — 19 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: plasmapheresis (Drug); Bortezomib (Drug); Rituximab (Drug); Methylprednisolone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Nov 2012

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	—

Summary

To determine if deletional strategies will provide effective desensitization.

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

View full record on ClinicalTrials.gov →

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.