Trial Outcomes & Findings for Impact of Proteasome Inhibition on Anti-Donor HLA Antibody Production After Kidney Transplantation (NCT NCT01349595)
NCT ID: NCT01349595
Last Updated: 2015-10-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
60 months after enrollment in the study
Results posted on
2015-10-28
Participant Flow
Subjects were recruited from the Mayo Clinic transplant program in Rochester, Minnesota.
Participant milestones
| Measure |
Bortezomib
Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).
|
Standard Post-transplant Treatment
Mayo Clinic standard post kidney transplant follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Bortezomib
Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).
|
Standard Post-transplant Treatment
Mayo Clinic standard post kidney transplant follow-up.
|
|---|---|---|
|
Overall Study
Lack of funding
|
2
|
2
|
Baseline Characteristics
Impact of Proteasome Inhibition on Anti-Donor HLA Antibody Production After Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Bortezomib
n=2 Participants
Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).
|
Standard Post-transplant Treatment
n=2 Participants
Mayo Clinic standard post kidney transplant follow-up.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 months after enrollment in the studyPopulation: Results data for zero participants were analyzed; long-term follow-up evaluation of participants was not possible due to discontinuation of funding.
Outcome measures
Outcome data not reported
Adverse Events
Bortezomib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Post-transplant Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bortezomib
n=2 participants at risk
Bortezomib is a type of targeted chemotherapy
Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).
|
Standard Post-transplant Treatment
n=2 participants at risk
Mayo Clinic standard post kidney transplant follow-up.
|
|---|---|---|
|
Gastrointestinal disorders
nausea/vomiting
|
100.0%
2/2 • Number of events 2 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
|
General disorders
fatigue
|
100.0%
2/2 • Number of events 2 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
|
General disorders
Pain at injection site
|
50.0%
1/2 • Number of events 1 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
50.0%
1/2 • Number of events 1 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
|
Metabolism and nutrition disorders
dehydration
|
50.0%
1/2 • Number of events 1 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
50.0%
1/2 • Number of events 1 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • 60 months after kidney transplantation
|
0.00%
0/2 • 60 months after kidney transplantation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place