Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00167661
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 95
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.

Condition or Disease	Intervention/Treatment	Phase
Disorder Related to Renal Transplantation	Drug: Campath-1H	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Campath 1-H Campath 1-H	Drug: Campath-1H; two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant; Other Names: Alemtuzumab

Outcome Measures

Primary Outcome Measures

1. Incidence of Graft Rejection [at 1, 3, 6, 12, and 24 months]

2. Participant Graft Survival [at 6, 12, and 24 months]

Secondary Outcome Measures

1. Estimated Glomerular Filtration Rate (EGFR) [at 1, 6, 12 and 24 months]

   Measure of renal function

2. Number of Participants With Infection [up to 24 months]

   Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)

3. Number of Participants With Malignancy [up to 24 months]

4. Growth Post-transplant Reported by Height Z Score [up to 24 months]

   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.

5. Number of Participants With Hypertension [up to 24 months]

6. Number of Participants With Hyperlipidemia [up to 24 months]

7. Participant Survival [at 6, 12, and 24 months]

8. Number of Participant With Diabetes Mellitus [up to 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants must be a single-organ recipient (kidney only)

• Participants who are receiving their first living donor or deceased donor transplant

Exclusion Criteria:

• Participants who are recipients of HLA-identical living-donor renal transplants

• Participants with a PRA value > 10% within 30 days prior to the transplant

• Participants who have received a multi-organ transplant

• Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV

• Participants who have received an investigational drug within 6 weeks of study entry

• Participants who have a previous history of, or who currently have, malignancies and/or lymphoma

• Participants who have received corticosteroids within three months of transplantation

• Participants who are 3rd transplant recipients

• Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Study Chair: Sharon M Bartosh, MD, University of Wisconsin, Madison
• Principal Investigator: Sharon M Bartosh, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00167661
• Other Study ID Numbers: 2011-0661; H-2003-0493; A536758; SMPH/PEDIATRICS/PEDIATRICS
• First Posted: Sep 14, 2005
• Last Update Posted: Sep 21, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Wisconsin, Madison: living or deceased donor renal transplant recipient
• Additional relevant MeSH terms: Alemtuzumab

Study Results

Participant Flow

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Period Title: Overall Study
STARTED	33
COMPLETED	33
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Overall Participants	33
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	11.8
Sex: Female, Male (Count of Participants)
Female	9 27.3%
Male	24 72.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3%
Not Hispanic or Latino	32 97%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 3%
Asian	1 3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 12.1%
White	26 78.8%
More than one race	0 0%
Unknown or Not Reported	1 3%
Region of Enrollment (participants) [Number]
United States	33 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Graft Rejection
Time Frame	at 1, 3, 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
1 month	0 0%
3 months	2 6.1%
6 months	6 18.2%
12 months	10 30.3%
24 months	11 33.3%

2. Primary Outcome

Title	Participant Graft Survival
Time Frame	at 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
6 months	32 97%
12 months	32 97%
24 months	32 97%

3. Secondary Outcome

Title	Estimated Glomerular Filtration Rate (EGFR)
Description	Measure of renal function
Time Frame	at 1, 6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

One participant was on dialysis at 2 years, not included in the analysis

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
1 month	91.5
6 months	88.4
12 months	85.8
24 months	77.4

4. Secondary Outcome

Title	Number of Participants With Infection
Description	Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
BK Nephropathy	2 6.1%
BK Viremia	10 30.3%
BK Viruria	12 36.4%
CMV Viremia	4 12.1%
CMV disease	0 0%
EBV Viremia	1 3%
EBV disease	0 0%

5. Secondary Outcome

Title	Number of Participants With Malignancy
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Growth Post-transplant Reported by Height Z Score
Description	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.
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

One participant was on dialysis at 2 years, not included in the analysis

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
baseline	-0.99
12 months	-0.41
24 months	-0.35

7. Secondary Outcome

Title	Number of Participants With Hypertension
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
Count of Participants [Participants]	27 81.8%

8. Secondary Outcome

Title	Number of Participants With Hyperlipidemia
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
Count of Participants [Participants]	0 0%

9. Secondary Outcome

Title	Participant Survival
Time Frame	at 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
6 months	33 100%
12 months	33 100%
24 months	33 100%

10. Secondary Outcome

Title	Number of Participant With Diabetes Mellitus
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Measure Participants	33
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	up to 24 months
Arm/Group Title	Campath 1-H
Arm/Group Description	Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
All Cause Mortality
	Campath 1-H
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Serious Adverse Events
	Campath 1-H
	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)
Renal and urinary disorders
Pyuria	1/33 (3%)
Proteinuria	1/33 (3%)
Increase Creatinine	1/33 (3%)
Other (Not Including Serious) Adverse Events
	Campath 1-H
	Affected / at Risk (%)	# Events
Total	29/33 (87.9%)
Blood and lymphatic system disorders
Neutropenia	4/33 (12.1%)
Neutropenia	9/33 (27.3%)
Eosinophilia	1/33 (3%)
Leukopenia	5/33 (15.2%)
Lymphoid hyperplasia	1/33 (3%)
Cardiac disorders
Left ventricular hypertrophy	1/33 (3%)
Ear and labyrinth disorders
Ottis Media	2/33 (6.1%)
Gastrointestinal disorders
Diarrhea	7/33 (21.2%)
Small Bowel Obstruction	2/33 (6.1%)
Epigastric Pain	1/33 (3%)
Nausea and Vomiting	3/33 (9.1%)
General disorders
Fever	3/33 (9.1%)
Dehydration	3/33 (9.1%)
Chest Pain	1/33 (3%)
fatigue	1/33 (3%)
Headache	2/33 (6.1%)
Joint Pain	1/33 (3%)
Hepatobiliary disorders
Hepatosplenomegaly	1/33 (3%)
Immune system disorders
Tonsillar cervical, axillary, inguinal hypertrophy	7/33 (21.2%)
Hives	1/33 (3%)
Infections and infestations
Gingivitis	1/33 (3%)
influenza	3/33 (9.1%)
Urinary Tract Infection	2/33 (6.1%)
Pseudomonas bacteremia	1/33 (3%)
Varicella	2/33 (6.1%)
Pneumonia	3/33 (9.1%)
Injury, poisoning and procedural complications
Fracture L5	1/33 (3%)
Metabolism and nutrition disorders
Anemia	1/33 (3%)
Hyperglycemia	2/33 (6.1%)
Hyperkalemia	1/33 (3%)
Hyperphosphatemia	1/33 (3%)
Weight Loss	1/33 (3%)
Metabolic acidosis	1/33 (3%)
Nervous system disorders
Seizure	1/33 (3%)
Fine tremor at rest	1/33 (3%)
Renal and urinary disorders
Ureteral Stricture	1/33 (3%)
Pyelonephritis	1/33 (3%)
Hydronephrosis	1/33 (3%)
Hydroureter	1/33 (3%)
Elevated Creatinine	9/33 (27.3%)
Increased Proteinuria	3/33 (9.1%)
Pyuria	1/33 (3%)
Renal Insufficiency	1/33 (3%)
Urinary Eosinophils	1/33 (3%)
Respiratory, thoracic and mediastinal disorders
Bronchitis	1/33 (3%)
Bronchospasm	11/33 (33.3%)
Cough	9/33 (27.3%)
Pulmonary Edema	1/33 (3%)
Shortness of Breath	2/33 (6.1%)
Nasal Congestion	2/33 (6.1%)
Rhinorrhea	3/33 (9.1%)
Sore Throat	3/33 (9.1%)
Skin and subcutaneous tissue disorders
Mouth Ulcers	2/33 (6.1%)
Rash	5/33 (15.2%)
Vascular disorders
High Blood Pressure	2/33 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.