Trial Outcomes & Findings for Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys (NCT NCT00001984)
NCT ID: NCT00001984
Last Updated: 2016-10-27
Results Overview
The renal allograft tolerance was evaluated clinically, by flow cytometry, and by protocol biopsies analyzed immunohistochemically and with real-time polymerase chain reaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
from day 1 to 24 months post operation
Results posted on
2016-10-27
Participant Flow
Five patients aged 28-54 years scheduled to receive their first live-donor kidney transplant were enrolled after informed consent for study participation was obtained.
Patients were excluded if they were: HLA identical with their donor; on immunosuppression within 6 months of enrollment; or medically unsuitable for transplantation. Cytomegalovirus negative recipients of cytomegalovirus positive grafts were excluded.
Participant milestones
| Measure |
Alemtuzumab and DSG
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
Baseline characteristics by cohort
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
40 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
|
Relationship between Donor and Recepient
Living related
|
3 participants
n=99 Participants
|
|
Relationship between Donor and Recepient
Living unrelated
|
2 participants
n=99 Participants
|
|
Cause of end-stage renal disease
Membranous glomerulonephritis
|
1 participants
n=99 Participants
|
|
Cause of end-stage renal disease
IgA nephropathy
|
1 participants
n=99 Participants
|
|
Cause of end-stage renal disease
Polycystic kidney disease
|
1 participants
n=99 Participants
|
|
Cause of end-stage renal disease
Medullary cystic disease
|
1 participants
n=99 Participants
|
|
Cause of end-stage renal disease
Obstructive uropathy
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: from day 1 to 24 months post operationThe renal allograft tolerance was evaluated clinically, by flow cytometry, and by protocol biopsies analyzed immunohistochemically and with real-time polymerase chain reaction.
Outcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Number of Patients With Renal Allograft Rejection
|
5 participant
|
PRIMARY outcome
Timeframe: From day 1 to 2 years post operationThe day on which the rejection onsets.
Outcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Rejection Day of Onset
|
28 day
Interval 24.0 to 32.0
|
PRIMARY outcome
Timeframe: 24-32 days post operationOutcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Rise in Serum Creatineine Above Posttransplant Nadir
|
58 parcentage rise in serum creatineine
Interval 20.0 to 530.0
|
SECONDARY outcome
Timeframe: 6 month post operationOutcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Creatinine Level at 6 Month Post Operation
|
1.5 mg/dL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 year post operationOutcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Creatinine Level at Year 1 Post Operation
|
1.4 mg/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 2 years post operationCreatinine level of donor recepient at 2 years after transplantation
Outcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Creatinine at 2 Years
|
1.7 mg/dL
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 4 day post operationOutcome measures
| Measure |
Alemtuzumab and DSG
n=5 Participants
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Monocyte Count
|
527 cells/mm3
Interval 370.0 to 1600.0
|
Adverse Events
Alemtuzumab and DSG
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alemtuzumab and DSG
n=5 participants at risk
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Renal and urinary disorders
Allograft Rejection
|
100.0%
5/5 • Number of events 5
|
Other adverse events
| Measure |
Alemtuzumab and DSG
n=5 participants at risk
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
|
|---|---|
|
Renal and urinary disorders
postbiopsy hemodynamically significant renal arteriovenous fistula
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Grade II chronic allograft nepharopathy with proteinuria
|
40.0%
2/5 • Number of events 2
|
|
Renal and urinary disorders
Grade II CAN at year 1 post operation
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
OKT3 rescue requirement
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
5/5 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
5/5 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place