Trial Outcomes & Findings for CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients (NCT NCT03591380)
NCT ID: NCT03591380
Last Updated: 2023-01-09
Results Overview
Use descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function as determined by serum creatinine/eGFR and urine protein, rates of acute cellular and antibody mediated rejection.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
12 months from the time of transplant.
Results posted on
2023-01-09
Participant Flow
Participant milestones
| Measure |
Experimental: Belimumab
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Overall Study
STARTED
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3
|
|
Overall Study
COMPLETED
|
3
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Age, Customized
30-39 years
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2 Participants
n=93 Participants
|
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Age, Customized
40-49 years
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1 Participants
n=93 Participants
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Sex: Female, Male
Female
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2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 months from the time of transplant.Use descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function as determined by serum creatinine/eGFR and urine protein, rates of acute cellular and antibody mediated rejection.
Outcome measures
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Number of Participants That Are DSA Positive as Measured by Mean Fluorescence Intensity Greater Than Zero for DSA
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0 Participants
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SECONDARY outcome
Timeframe: 12 months from the time of transplantUse descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function, and rates of acute cellular and antibody mediated rejection
Outcome measures
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Number of Participants With DSA Development, Graft Survival, and Cellular and Antibody Rejection
DSA development
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0 Participants
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Number of Participants With DSA Development, Graft Survival, and Cellular and Antibody Rejection
graft survival
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3 Participants
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Number of Participants With DSA Development, Graft Survival, and Cellular and Antibody Rejection
cellular and antibody rejection
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0 Participants
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SECONDARY outcome
Timeframe: Monitored for 12 months from the time of transplantUse descriptive statistics to report the nature, frequency, and severity of serious and non-serious adverse events greater than or equal to Grade 2.
Outcome measures
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Seroma
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Abdominal Infection
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Fever
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Escherichia coli bacteremia from urinary tract infection
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Ureteral Revision
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Urine Leak
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Anaphylaxis
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Pseudomonas Aeruginosa Urinary Tract Infection
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 2 : Urinary Tract Infection
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Seroma
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Abdominal Infection
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Fever
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Escherichia coli bacteremia from urinary tract infection
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Ureteral Revision
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1 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Urine Leak
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Anaphylaxis
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0 participants
|
|
Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Pseudomonas Aeruginosa Urinary Tract Infection
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0 participants
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Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Grade 3 : Urinary Tract Infection
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0 participants
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SECONDARY outcome
Timeframe: 1, 3, 6, 9, and 12 months from the time of transplantUse descriptive statistics to describe the rate of graft survival and function as determined by serum creatinine
Outcome measures
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Graft Survival and Function by Serum Creatinine
Serum Creatinine month 1
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3.75 mg/dL
Interval 1.42 to 8.43
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Graft Survival and Function by Serum Creatinine
Serum Creatinine month 3
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1.85 mg/dL
Interval 1.2 to 3.01
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Graft Survival and Function by Serum Creatinine
Serum Creatinine month 6
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1.57 mg/dL
Interval 1.18 to 2.31
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Graft Survival and Function by Serum Creatinine
Serum Creatinine month 9
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1.25 mg/dL
Interval 1.08 to 1.42
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Graft Survival and Function by Serum Creatinine
Serum Creatinine month 12
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1.54 mg/dL
Interval 1.18 to 2.07
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SECONDARY outcome
Timeframe: 1, 3, 6, 9, and 12 months from the time of transplantUse descriptive statistics to describe the rate of graft survival and function as determined by eGFR.
Outcome measures
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Graft Survival and Function by eGFR
eGFR month 1
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33.33 mL/min/1.73m2
Interval 7.0 to 49.0
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Graft Survival and Function by eGFR
eGFR month 3
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43.67 mL/min/1.73m2
Interval 26.0 to 53.0
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Graft Survival and Function by eGFR
eGFR month 6
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49 mL/min/1.73m2
Interval 35.0 to 58.0
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Graft Survival and Function by eGFR
eGFR month 9
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55.5 mL/min/1.73m2
Interval 43.0 to 68.0
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Graft Survival and Function by eGFR
eGFR month 12
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48.67 mL/min/1.73m2
Interval 40.0 to 61.0
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SECONDARY outcome
Timeframe: 1, 3, 6, 9, and 12 months from the time of transplantUse descriptive statistics to describe the rate of graft survival and function as determined by urine protein.
Outcome measures
| Measure |
Experimental: Belimumab
n=3 Participants
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Graft Survival and Function by Urine Protein
Urine protein month 1
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28.37 milligrams
Interval 18.3 to 44.7
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Graft Survival and Function by Urine Protein
Urine protein month 3
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16.4 milligrams
Interval 6.8 to 31.0
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Graft Survival and Function by Urine Protein
Urine protein month 6
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11.65 milligrams
Interval 6.8 to 16.5
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Graft Survival and Function by Urine Protein
Urine protein month 9
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10 milligrams
Interval 6.0 to 18.0
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Graft Survival and Function by Urine Protein
Urine protein month 12
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6.53 milligrams
Interval 6.0 to 7.6
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Adverse Events
Experimental: Belimumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Belimumab
n=3 participants at risk
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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General disorders
fever
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33.3%
1/3 • Number of events 2 • 12 months after transplant.
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Infections and infestations
Escherichia coli bacteremis from UTI
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
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Injury, poisoning and procedural complications
Ureteral Revision
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33.3%
1/3 • Number of events 1 • 12 months after transplant.
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Renal and urinary disorders
Urine Leak
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33.3%
1/3 • Number of events 1 • 12 months after transplant.
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Infections and infestations
Klebsiella Pneumoniae UTI
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33.3%
1/3 • Number of events 1 • 12 months after transplant.
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Infections and infestations
Pseudomonas Aeruginosa UTI
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
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Immune system disorders
Anaphylaxis
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
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Renal and urinary disorders
Subtotal Parathyroidectomy
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
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General disorders
Post-surgical fluid collection
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
Other adverse events
| Measure |
Experimental: Belimumab
n=3 participants at risk
Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks.
Belimumab: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
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|---|---|
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Infections and infestations
Urinary Tract Infection
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
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Nervous system disorders
tremors
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
General disorders
Elevated Donor Specific Antibody
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
General disorders
Forgetfulness
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
General disorders
Night Sweats
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Blood and lymphatic system disorders
Generalized Edema
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 2 • 12 months after transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • 12 months after transplant.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 3 • 12 months after transplant.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 2 • 12 months after transplant.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Infections and infestations
Abdominal infection
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Musculoskeletal and connective tissue disorders
Right distal fibula fracture
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 3 • 12 months after transplant.
|
|
Renal and urinary disorders
Glucosuria
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Renal and urinary disorders
Urinary Urgency
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Renal and urinary disorders
Delayed Graft Function
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Renal and urinary disorders
Bladder Spasms
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Renal and urinary disorders
Urine Leak
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Surgical and medical procedures
Seroma
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Surgical and medical procedures
Right Genitofemoral Neuralgia
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Surgical and medical procedures
Post operative pain at drain site
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
|
Immune system disorders
Cytomegalovirus
|
33.3%
1/3 • Number of events 1 • 12 months after transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place