Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00214201
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 72
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.

Condition or Disease	Intervention/Treatment	Phase
Primary Renal Transplant	Drug: Calcineurin inhibitor withdrawal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 Standard of Care CNI immunosuppression
Experimental: 2 Calcineurin inhibitor withdrawal	Drug: Calcineurin inhibitor withdrawal; stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Biopsy Proven Rejection [3 years]

Secondary Outcome Measures

1. Serum Creatinine at 36 Months (End of Study) [36 months +/- 60 days]

Other Outcome Measures

1. WBC [36 months +/- 60 days]

   White Blood Cell count

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.

Exclusion Criteria:

• Recipients of HLA-identical living-donor renal transplants;

• PRA value >20% within 30 days of transplant;

• GFR <40ml/min;

• multi-organ transplant;

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 Knechtle, 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: NCT00214201
• Other Study ID Numbers: 2003-125
• First Posted: Sep 21, 2005
• Last Update Posted: Oct 3, 2012
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Calcineurin Inhibitors

Study Results

Participant Flow

Arm/Group Title	CNI Control Post Campath 1H	CNI Withdrawal Post Campath 1H
Arm/Group Description	Standard of Care CNI immunosuppression	Calcineurin inhibitor withdrawal Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	18
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	CNI Control Post Campath 1H	CNI Withdrawal Post Campath 1H	Total
Arm/Group Description	Standard of Care CNI immunosuppression	Calcineurin inhibitor withdrawal Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 80%	17 85%	33 82.5%
>=65 years	4 20%	3 15%	7 17.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.1 (9.2)	55.3 (9.4)	54.7 (9.2)
Sex: Female, Male (Count of Participants)
Female	3 15%	5 25%	8 20%
Male	17 85%	15 75%	32 80%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Biopsy Proven Rejection
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CNI Control Post Campath 1H	CNI Withdrawal Post Campath 1H
Arm/Group Description	Standard of Care CNI immunosuppression	Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Measure Participants	20	20
Number [participants]	2 10%	7 35%

2. Secondary Outcome

Title	Serum Creatinine at 36 Months (End of Study)
Time Frame	36 months +/- 60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CNI Control Post Campath 1H	CNI Withdrawal Post Campath 1H
Arm/Group Description	Standard of care CNI Immunosuppression	Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Measure Participants	18	18
Mean (Standard Deviation) [mg/dl]	1.49 (.44)	1.37 (.35)

3. Other Pre-specified Outcome

Title	WBC
Description	White Blood Cell count
Time Frame	36 months +/- 60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CNI Control Post Campath 1H	CNI Withdrawal Post Campath 1H
Arm/Group Description	Standard of Care CNI immunosuppression	Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Measure Participants	18	18
Mean (Standard Deviation) [K/ul]	7.10 (1.69)	7.68 (2.05)

Adverse Events

Arm/Group Title	CNI Control Post Campath 1H		CNI Withdrawal Post Campath 1H
Arm/Group Description	Standard of Care CNI immunosuppression		Calcineurin inhibitor withdrawal Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
All Cause Mortality
	CNI Control Post Campath 1H		CNI Withdrawal Post Campath 1H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CNI Control Post Campath 1H		CNI Withdrawal Post Campath 1H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/20 (55%)		8/20 (40%)
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura (ITP),	1/20 (5%)	2	0/20 (0%)	0
Cardiac disorders
Atrial Fibrillaiton	0/20 (0%)	0	1/20 (5%)	1
myocardial infarction	1/20 (5%)	1	0/20 (0%)	0
congestive heart failure	1/20 (5%)	1	0/20 (0%)	0
Gastrointestinal disorders
gastritis (viral)	1/20 (5%)	1	0/20 (0%)	0
Immune system disorders
kidney transplant rejection	1/20 (5%)	1	2/20 (10%)	3
Infections and infestations
cytomegalovirus	2/20 (10%)	2	2/20 (10%)	2
campylobacteremia	0/20 (0%)	0	1/20 (5%)	1
Camplobacter gastroenteritis	1/20 (5%)	1	0/20 (0%)	0
Varicella Zoster	1/20 (5%)	1	0/20 (0%)	0
Cryptococcal Meningitis	1/20 (5%)	1	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
back pain	0/20 (0%)	0	1/20 (5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid cancer	0/20 (0%)	0	1/20 (5%)	1
Nervous system disorders
encephalitis	0/20 (0%)	0	1/20 (5%)	1
Renal and urinary disorders
hydronephrosis	1/20 (5%)	1	3/20 (15%)	3
urinary tract infection	1/20 (5%)	1	1/20 (5%)	1
Respiratory, thoracic and mediastinal disorders
pneumonia	1/20 (5%)	1	0/20 (0%)	0
Chronic Obstructive Pulmonary Disease	2/20 (10%)	2	0/20 (0%)	0
Surgical and medical procedures
thryoidectomy	0/20 (0%)	0	1/20 (5%)	1
hernia repair	0/20 (0%)	0	1/20 (5%)	1
Coronary artery bypass grafting (CABG)	1/20 (5%)	1	0/20 (0%)	0
Cholecystectomy	1/20 (5%)	1	0/20 (0%)	0
Vascular disorders
Cerebrovascular accident	0/20 (0%)	0	1/20 (5%)	3
Other (Not Including Serious) Adverse Events
	CNI Control Post Campath 1H		CNI Withdrawal Post Campath 1H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/20 (50%)		11/20 (55%)
Eye disorders
Iritis, left eye	1/20 (5%)	1	0/20 (0%)	0
Gastrointestinal disorders
Constipation	1/20 (5%)	2	0/20 (0%)	0
Infections and infestations
BK Polyoma viuria	3/20 (15%)	3	2/20 (10%)	2
sinusitis	0/20 (0%)	0	1/20 (5%)	1
Cytomegalovirus	1/20 (5%)	1	2/20 (10%)	2
Herpes Zoster	4/20 (20%)	4	1/20 (5%)	1
E. Coli Urinary Tract Infection	2/20 (10%)	2	1/20 (5%)	1
Klebsiella pneumoniae Urinary Tract infection	0/20 (0%)	0	1/20 (5%)	1
Acinetobacter Baumannii Urinary Tract infection	0/20 (0%)	0	1/20 (5%)	1
Streptococcal Urinary Tract infection	0/20 (0%)	0	1/20 (5%)	1
CMV retinitis	1/20 (5%)	1	0/20 (0%)	0
Epstein Barr Virus	1/20 (5%)	1	0/20 (0%)	0
Renal and urinary disorders
urinary tract infection	1/20 (5%)	1	3/20 (15%)	5
Respiratory, thoracic and mediastinal disorders
Bronchitis	0/20 (0%)	0	1/20 (5%)	1
pneumonia	0/20 (0%)	0	1/20 (5%)	1
Upper Respiratory Tract infection	0/20 (0%)	0	2/20 (10%)	2
Skin and subcutaneous tissue disorders
Dental Abcess	0/20 (0%)	0	1/20 (5%)	1
Boil (groin)	1/20 (5%)	1	0/20 (0%)	0

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.