"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00365846
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 71
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant	Drug: Campath-1H	Phase 2

Detailed Description

Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.

Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation
• Study Start Date: Aug 1, 2000
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Campath 1H induction w/ Sirolimus immunosuppression Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,	Drug: Campath-1H

Outcome Measures

Primary Outcome Measures

1. Incidence of Allograft Rejection [3 years]

Secondary Outcome Measures

1. Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) [3 years]

2. Patient Survival [3 years]

3. Incidence of Post-transplant Infection [3 years]

   Event of post-transplant infection (more than one "event" might have been counted per participant)

4. Incidence of Malignancies [3 years]

   Number of Participants Experiencing Malignancies

5. Kidney Allograft Survival [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• primary renal transplant (not HLA identical)

• ages 18-60 years

Exclusion Criteria:

• recipient panel reactive antibody level >10%

• recipient of a DCD kidney

• no prior organ transplant

• no multi-organ transplant recipient

• no subject who is currently receiving systemic corticosteroids

• no pregnant or lactating subjects

• no history of Hepatitis B, C or HIV positivity

• no recipient of a kidney with cold ischemia time >36 hours

Contacts and Locations

Locations

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

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Stuart J Knechtle, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00365846
• Other Study ID Numbers: 2000-032
• First Posted: Aug 18, 2006
• Last Update Posted: Oct 3, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by University of Wisconsin, Madison: prevent kidney rejection
• Additional relevant MeSH terms: Alemtuzumab

Study Results

Participant Flow

Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Period Title: Overall Study
STARTED	29
COMPLETED	28
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Overall Participants	29
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	41
Sex: Female, Male (Count of Participants)
Female	10 34.5%
Male	19 65.5%
Region of Enrollment (participants) [Number]
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Allograft Rejection
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Measure Participants	28
Number [participants]	13 44.8%

2. Secondary Outcome

Title	Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Measure Participants	28
Number [participants]	6 20.7%

3. Secondary Outcome

Title	Patient Survival
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Measure Participants	28
Number [participants]	28 96.6%

4. Secondary Outcome

Title	Incidence of Post-transplant Infection
Description	Event of post-transplant infection (more than one "event" might have been counted per participant)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Campath 1H Induction w/ Sirolimus Immunosuppression
Arm/Group Description	Campath 1H induction on Day -1 and 0 of renal transplant followed w/ Sirolimus maintenance immunosuppression
Measure Participants	28
Number [event of infection]	28

5. Secondary Outcome

Title	Incidence of Malignancies
Description	Number of Participants Experiencing Malignancies
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1Campath 1H Induction w/ Sirolimus Immunosuppression
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Measure Participants	28
Number [participants]	2 6.9%

6. Secondary Outcome

Title	Kidney Allograft Survival
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
Measure Participants	28
Number [participants]	27 93.1%

Adverse Events

Time Frame	Reported Adverse Events include events starting on of after Day 0 (day of Transplant) and on or before Month 36.
Adverse Event Reporting Description	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
Arm/Group Title	Group 1
Arm/Group Description	Campath 1H induction w/ Sirolimus immunosuppression
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	19/28 (67.9%)
Blood and lymphatic system disorders
Anemia	2/28 (7.1%)	2
Cardiac disorders
Congestive Heart Failure	1/28 (3.6%)	1
myocardial Infarction	1/28 (3.6%)	1
Endocrine disorders
secondary hyperparathyroidism	1/28 (3.6%)	1
General disorders
Fever of unknown origin	2/28 (7.1%)	2
hypocalcemia	1/28 (3.6%)	1
Infections and infestations
Herpes Zoster	3/28 (10.7%)	3
Herpes simplex	5/28 (17.9%)	5
Pneumonia	5/28 (17.9%)	5
Urinary tract infection	10/28 (35.7%)	15
urosepsis	1/28 (3.6%)	1
Injury, poisoning and procedural complications
drug toxicity	1/28 (3.6%)	1
Musculoskeletal and connective tissue disorders
Gout	1/28 (3.6%)	1
abdominal hernia	7/28 (25%)	8
intra abdominal abcess	2/28 (7.1%)	2
right ankle fracture	1/28 (3.6%)	1
Nervous system disorders
bilateral extremity weakness	1/28 (3.6%)	1
Renal and urinary disorders
Acute kidney graft rejection	13/28 (46.4%)	24
Renal Hematoma	1/28 (3.6%)	1
Renal parenchyma leak	1/28 (3.6%)	1
Vesico-ureteral reflux	1/28 (3.6%)	1
acute renal insufficiency	2/28 (7.1%)	2
kidney graft failure	1/28 (3.6%)	1
lymphocele	2/28 (7.1%)	2
pyelonephritis	1/28 (3.6%)	1
ureteral stricture	1/28 (3.6%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	1/28 (3.6%)	1
Skin and subcutaneous tissue disorders
basal cell skin cancer	2/28 (7.1%)	2
Vascular disorders
Deep vein thrombosis	2/28 (7.1%)	2
Iliac artery stenosis	1/28 (3.6%)	1
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	28/28 (100%)
Blood and lymphatic system disorders
anemia	10/28 (35.7%)	10
leukopenia	5/28 (17.9%)	5
Ear and labyrinth disorders
sleep apnea	2/28 (7.1%)	2
Endocrine disorders
hyperlipidemia	19/28 (67.9%)	19
hyperglysemia	4/28 (14.3%)	4
Eye disorders
cataracts	2/28 (7.1%)	2
Gastrointestinal disorders
Gastroesophageal reflux	7/28 (25%)	7
Hepatobiliary disorders
elevated liver enzymes	7/28 (25%)	7
Injury, poisoning and procedural complications
laceration	2/28 (7.1%)	2
Musculoskeletal and connective tissue disorders
osteopenia	6/28 (21.4%)	6
edema	5/28 (17.9%)	5
Psychiatric disorders
insomnia	3/28 (10.7%)	3
Renal and urinary disorders
proteinuria	5/28 (17.9%)	5
Reproductive system and breast disorders
erectile dysfunction	4/19 (21.1%)	4
amenorrhea	2/7 (28.6%)	2
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection	7/28 (25%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.