Trial Outcomes & Findings for "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation" (NCT NCT00365846)
NCT ID: NCT00365846
Last Updated: 2012-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
3 years
Results posted on
2012-10-03
Participant Flow
Participant milestones
| Measure |
Group 1
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Group 1
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
Baseline characteristics by cohort
| Measure |
Group 1
n=29 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Group 1
n=28 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Incidence of Allograft Rejection
|
13 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Group 1
n=28 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
|
6 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Group 1
n=28 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Patient Survival
|
28 participants
|
SECONDARY outcome
Timeframe: 3 yearsEvent of post-transplant infection (more than one "event" might have been counted per participant)
Outcome measures
| Measure |
Group 1
n=28 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Incidence of Post-transplant Infection
|
28 event of infection
|
SECONDARY outcome
Timeframe: 3 yearsNumber of Participants Experiencing Malignancies
Outcome measures
| Measure |
Group 1
n=28 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Incidence of Malignancies
|
2 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Group 1
n=28 Participants
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Kidney Allograft Survival
|
27 participants
|
Adverse Events
Group 1
Serious events: 19 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=28 participants at risk
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Renal and urinary disorders
Acute kidney graft rejection
|
46.4%
13/28 • Number of events 24 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Cardiac disorders
Congestive Heart Failure
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Vascular disorders
Deep vein thrombosis
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
General disorders
Fever of unknown origin
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Musculoskeletal and connective tissue disorders
Gout
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Infections and infestations
Herpes Zoster
|
10.7%
3/28 • Number of events 3 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Infections and infestations
Herpes simplex
|
17.9%
5/28 • Number of events 5 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Vascular disorders
Iliac artery stenosis
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Infections and infestations
Pneumonia
|
17.9%
5/28 • Number of events 5 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
Renal Hematoma
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
Renal parenchyma leak
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Infections and infestations
Urinary tract infection
|
35.7%
10/28 • Number of events 15 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
Vesico-ureteral reflux
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Musculoskeletal and connective tissue disorders
abdominal hernia
|
25.0%
7/28 • Number of events 8 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
acute renal insufficiency
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Skin and subcutaneous tissue disorders
basal cell skin cancer
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Nervous system disorders
bilateral extremity weakness
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Injury, poisoning and procedural complications
drug toxicity
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
General disorders
hypocalcemia
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Musculoskeletal and connective tissue disorders
intra abdominal abcess
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
kidney graft failure
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
lymphocele
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Cardiac disorders
myocardial Infarction
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
pyelonephritis
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Musculoskeletal and connective tissue disorders
right ankle fracture
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Endocrine disorders
secondary hyperparathyroidism
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
ureteral stricture
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Infections and infestations
urosepsis
|
3.6%
1/28 • Number of events 1 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
Other adverse events
| Measure |
Group 1
n=28 participants at risk
Campath 1H induction w/ Sirolimus immunosuppression
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
35.7%
10/28 • Number of events 10 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Endocrine disorders
hyperlipidemia
|
67.9%
19/28 • Number of events 19 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Endocrine disorders
hyperglysemia
|
14.3%
4/28 • Number of events 4 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Renal and urinary disorders
proteinuria
|
17.9%
5/28 • Number of events 5 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Blood and lymphatic system disorders
leukopenia
|
17.9%
5/28 • Number of events 5 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
25.0%
7/28 • Number of events 7 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Musculoskeletal and connective tissue disorders
osteopenia
|
21.4%
6/28 • Number of events 6 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Psychiatric disorders
insomnia
|
10.7%
3/28 • Number of events 3 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Injury, poisoning and procedural complications
laceration
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Eye disorders
cataracts
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Ear and labyrinth disorders
sleep apnea
|
7.1%
2/28 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Reproductive system and breast disorders
erectile dysfunction
|
21.1%
4/19 • Number of events 4 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Hepatobiliary disorders
elevated liver enzymes
|
25.0%
7/28 • Number of events 7 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Musculoskeletal and connective tissue disorders
edema
|
17.9%
5/28 • Number of events 5 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
25.0%
7/28 • Number of events 7 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
|
Reproductive system and breast disorders
amenorrhea
|
28.6%
2/7 • Number of events 2 • Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
If a subject experienced more than 1 or a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place