Phase 2
N=41
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01178216 ↗Enrolled (actual)
41
Serious AEs
35.9%
Results posted
Sep 2018
Primary outcome: Primary: Number of Patients That Underwent Transplantation — 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituxan (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanley Jordan, MD
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Underwent Transplantation |
32 | — |
| SECONDARY Number of Patients With Allograft Survival |
28 | — |
| SECONDARY Reduction in Anti-HLA Antibodies |
76 | — |
| SECONDARY Number of Acute Rejection Episodes |
15 | — |
| SECONDARY Number of Patients Reporting a Serious Infection |
2 | — |
| SECONDARY Number of Adverse Events, Toxicity Assessments |
14 | — |
Summary
This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab. The trial will examine the safety and efficacy of human polyclonal IVIG 10%, when given at [2.0 gm/kgx2], + Rituximab 1gm to reduce donor-specific antibodies (DSA) to a level that is permissive for transplantation in 75 subjects (adults only ages >18 yrs) who are highly-HLA sensitized and are awaiting deceased donor kidney transplant. Once transplant offers are entertained, a donor-specific crossmatch will be performed. If acceptable crossmatches and DSA levels are seen, the patients will proceed to DD transplantation. Patients receiving transplants will receive an additional dose of IVIG at transplantation (within 10 days) and will receive additional doses of Rituximab 1g at 3M post transplant if DSA levels remain or become positive at 6M if de novo DSA occur. Patients who are desensitized and not transplanted at 9M after desensitization will have completed the study and can be treated as best judged by their physician.
Eligibility Criteria
Inclusion Criteria
- End-stage renal disease.
- No known contraindications for therapy with IGIV10%/Rituximab.
- Age 18-70 years at the time of screening.
- PRA> 30% demonstrated on 3 consecutive samples, UNOS wait time sufficient to allow DD offers, history of sensitizing events, positive crossmatch with the intended donor.
- Subject/Parent/Guardian must be able to understand and provide informed consent.
Exclusion Criteria
- Lactating or pregnant females.
- Pediatric patients 5X upper limit of normal, and an SGPT >5X upper limit of normal range.
- Individuals deemed unable to comply with the protocol.
- Subjects with active CMV or EBV infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness.
- Subjects with a known history of previous myocardial infarction within one year of screening.
- Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
- Use of investigational agents within 4 weeks of participation.
Data sourced from ClinicalTrials.gov (NCT01178216). 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.