Phase 2
N=30
Randomized Trial for Mixed Acute Rejection
Graft Rejection
Bottom Line
View on ClinicalTrials.gov: NCT00771875 ↗Enrolled (actual)
30
Serious AEs
65.5%
Results posted
Jan 2016
Primary outcome: Primary: Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection — 0; 0; 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rabbit Antithymocyte Globulin (RATG) (Drug); Rituximab (Drug); Bortezomib (Drug); Acetaminophen (Drug); Antihistamine (Drug); Methylprednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection |
0; 0; 0; 2; 1; 1 | — |
| SECONDARY Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy |
2; 2; 4 | — |
| SECONDARY Renal Allograft Survival |
7; 7; 10 | — |
| SECONDARY Mean Serum Creatinine |
3.04; 2.32; 2.31; 3.25; 2.35; 2.20 | — |
| SECONDARY Incidence of Death |
0; 0; 0 | — |
| SECONDARY Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy |
3; 3; 5 | — |
| SECONDARY Incidence of Post Transplant Lymphoproliferative Disorder (PTLD) |
0; 0; 0 | — |
Summary
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
Eligibility Criteria
Inclusion Criteria
Each subject must meet all of the following inclusion criteria to be enrolled in the study:
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use two acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Subject is between 18 and 65 years of age, inclusive.
- Subject has a transplant dysfunction indicated by an increase in creatinine of 0.3 mg/dL or 15% (lipase >3 X ULN for kidney/pancreas recipients) over baseline necessitating an allograft biopsy to assess for allograft rejection.
- Presence of light microscopic histologic changes consistent with acute cellular rejection of a Banff 97 (2005 update) grade IA or greater and at least one of the following:
- Donor-specific antibody (DSA) positive via Luminex
- Presence of C4d in the peritubular capillaries or glomeruli
- Subject must have no known contraindications to treatment with bortezomib, boron or mannitol, thymoglobulin, or rituximab.
- Recipients of kidney or simultaneous kidney pancreas organ transplant.
Exclusion Criteria
Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
- Subject has a platelet count 3 times upper limit of normal (ULN)) at screening.
- Pregnant or nursing (lactating) women.
- EBV sero-mismatch (EBV + donor organ transplanted to EBV - recipient)
- CMV sero-mismatch (CMV + donor organ transplanted to CMV - recipient)
Data sourced from ClinicalTrials.gov (NCT00771875). 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.