Trial Outcomes & Findings for Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation (NCT NCT00167661)
NCT ID: NCT00167661
Last Updated: 2020-09-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
at 1, 3, 6, 12, and 24 months
Results posted on
2020-09-21
Participant Flow
Participant milestones
| Measure |
Campath 1-H
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
Baseline characteristics by cohort
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Age, Continuous
|
11.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 1, 3, 6, 12, and 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Incidence of Graft Rejection
1 month
|
0 Participants
|
|
Incidence of Graft Rejection
3 months
|
2 Participants
|
|
Incidence of Graft Rejection
6 months
|
6 Participants
|
|
Incidence of Graft Rejection
12 months
|
10 Participants
|
|
Incidence of Graft Rejection
24 months
|
11 Participants
|
PRIMARY outcome
Timeframe: at 6, 12, and 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Participant Graft Survival
6 months
|
32 Participants
|
|
Participant Graft Survival
12 months
|
32 Participants
|
|
Participant Graft Survival
24 months
|
32 Participants
|
SECONDARY outcome
Timeframe: at 1, 6, 12 and 24 monthsPopulation: One participant was on dialysis at 2 years, not included in the analysis
Measure of renal function
Outcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Estimated Glomerular Filtration Rate (EGFR)
1 month
|
91.5 ml/min/1.73m^2
Interval 37.0 to 150.0
|
|
Estimated Glomerular Filtration Rate (EGFR)
6 months
|
88.4 ml/min/1.73m^2
Interval 15.0 to 161.0
|
|
Estimated Glomerular Filtration Rate (EGFR)
12 months
|
85.8 ml/min/1.73m^2
Interval 11.0 to 139.0
|
|
Estimated Glomerular Filtration Rate (EGFR)
24 months
|
77.4 ml/min/1.73m^2
Interval 25.0 to 126.0
|
SECONDARY outcome
Timeframe: up to 24 monthsCytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)
Outcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Number of Participants With Infection
BK Nephropathy
|
2 Participants
|
|
Number of Participants With Infection
BK Viremia
|
10 Participants
|
|
Number of Participants With Infection
BK Viruria
|
12 Participants
|
|
Number of Participants With Infection
CMV Viremia
|
4 Participants
|
|
Number of Participants With Infection
CMV disease
|
0 Participants
|
|
Number of Participants With Infection
EBV Viremia
|
1 Participants
|
|
Number of Participants With Infection
EBV disease
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Number of Participants With Malignancy
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: One participant was on dialysis at 2 years, not included in the analysis
A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean.
Outcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Growth Post-transplant Reported by Height Z Score
baseline
|
-0.99 z-score
Interval -5.0 to 1.25
|
|
Growth Post-transplant Reported by Height Z Score
12 months
|
-0.41 z-score
Interval -3.06 to 1.4
|
|
Growth Post-transplant Reported by Height Z Score
24 months
|
-0.35 z-score
Interval -2.31 to 1.33
|
SECONDARY outcome
Timeframe: up to 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Number of Participants With Hypertension
|
27 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Number of Participants With Hyperlipidemia
|
0 Participants
|
SECONDARY outcome
Timeframe: at 6, 12, and 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Participant Survival
24 months
|
33 Participants
|
|
Participant Survival
6 months
|
33 Participants
|
|
Participant Survival
12 months
|
33 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsOutcome measures
| Measure |
Campath 1-H
n=33 Participants
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Number of Participant With Diabetes Mellitus
|
0 Participants
|
Adverse Events
Campath 1-H
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Campath 1-H
n=33 participants at risk
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
Renal and urinary disorders
Pyuria
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Proteinuria
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Increase Creatinine
|
3.0%
1/33 • up to 24 months
|
Other adverse events
| Measure |
Campath 1-H
n=33 participants at risk
Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
|
|---|---|
|
General disorders
Fever
|
9.1%
3/33 • up to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.3%
9/33 • up to 24 months
|
|
Infections and infestations
Gingivitis
|
3.0%
1/33 • up to 24 months
|
|
Infections and infestations
influenza
|
9.1%
3/33 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
21.2%
7/33 • up to 24 months
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
2/33 • up to 24 months
|
|
Infections and infestations
Pseudomonas bacteremia
|
3.0%
1/33 • up to 24 months
|
|
Infections and infestations
Varicella
|
6.1%
2/33 • up to 24 months
|
|
General disorders
Dehydration
|
9.1%
3/33 • up to 24 months
|
|
Renal and urinary disorders
Ureteral Stricture
|
3.0%
1/33 • up to 24 months
|
|
Infections and infestations
Pneumonia
|
9.1%
3/33 • up to 24 months
|
|
Nervous system disorders
Seizure
|
3.0%
1/33 • up to 24 months
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
6.1%
2/33 • up to 24 months
|
|
Renal and urinary disorders
Pyelonephritis
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
3.0%
1/33 • up to 24 months
|
|
Gastrointestinal disorders
Epigastric Pain
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Hydroureter
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Elevated Creatinine
|
27.3%
9/33 • up to 24 months
|
|
Renal and urinary disorders
Increased Proteinuria
|
9.1%
3/33 • up to 24 months
|
|
Renal and urinary disorders
Pyuria
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Renal Insufficiency
|
3.0%
1/33 • up to 24 months
|
|
Renal and urinary disorders
Urinary Eosinophils
|
3.0%
1/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.0%
1/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
33.3%
11/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
9/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
3.0%
1/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
6.1%
2/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.1%
2/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
9.1%
3/33 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
9.1%
3/33 • up to 24 months
|
|
Immune system disorders
Tonsillar cervical, axillary, inguinal hypertrophy
|
21.2%
7/33 • up to 24 months
|
|
Metabolism and nutrition disorders
Anemia
|
3.0%
1/33 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.1%
2/33 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.0%
1/33 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
3.0%
1/33 • up to 24 months
|
|
Metabolism and nutrition disorders
Weight Loss
|
3.0%
1/33 • up to 24 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.0%
1/33 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Mouth Ulcers
|
6.1%
2/33 • up to 24 months
|
|
Immune system disorders
Hives
|
3.0%
1/33 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.2%
5/33 • up to 24 months
|
|
General disorders
Chest Pain
|
3.0%
1/33 • up to 24 months
|
|
General disorders
fatigue
|
3.0%
1/33 • up to 24 months
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
9.1%
3/33 • up to 24 months
|
|
General disorders
Headache
|
6.1%
2/33 • up to 24 months
|
|
General disorders
Joint Pain
|
3.0%
1/33 • up to 24 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.0%
1/33 • up to 24 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.2%
5/33 • up to 24 months
|
|
Blood and lymphatic system disorders
Lymphoid hyperplasia
|
3.0%
1/33 • up to 24 months
|
|
Nervous system disorders
Fine tremor at rest
|
3.0%
1/33 • up to 24 months
|
|
Injury, poisoning and procedural complications
Fracture L5
|
3.0%
1/33 • up to 24 months
|
|
Vascular disorders
High Blood Pressure
|
6.1%
2/33 • up to 24 months
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
3.0%
1/33 • up to 24 months
|
|
Cardiac disorders
Left ventricular hypertrophy
|
3.0%
1/33 • up to 24 months
|
|
Ear and labyrinth disorders
Ottis Media
|
6.1%
2/33 • up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place