Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys

This study has been completed.

Study NCT00001984 Information provided by National Institutes of Health Clinical Center (CC)

First Received on January 26, 2000. Last Updated on September 13, 2010 History of Changes

Results First Received: September 13, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Graft Rejection Kidney Disease
Intervention:	Drug: Alemtuzumab and DSG

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Five patients aged 28-54 years scheduled to receive their first live-donor kidney transplant were enrolled after informed consent for study participation was obtained.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they were: HLA identical with their donor; on immunosuppression within 6 months of enrollment; or medically unsuitable for transplantation. Cytomegalovirus negative recipients of cytomegalovirus positive grafts were excluded.

Reporting Groups

	Description
Alemtuzumab and DSG	The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.

Participant Flow: Overall Study

	Alemtuzumab and DSG
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Alemtuzumab and DSG	The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.

Baseline Measures

	Alemtuzumab and DSG
Number of Participants [units: participants]	5
Age [units: participants]
<=18 years	0
Between 18 and 65 years	5
>=65 years	0
Age [units: years] Median ( Full Range )	40 ( 28 to 54 )
Gender [units: participants]
Female	2
Male	3
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	5
More than one race	0
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	5
Relationship between Donor and Recepient [units: participants]
Living related	3
Living unrelated	2
Cause of end-stage renal disease [units: participants]
Membranous glomerulonephritis	1
IgA nephropathy	1
Polycystic kidney disease	1
Medullary cystic disease	1
Obstructive uropathy	1

Outcome Measures

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1. Primary:

Number of Patients With Renal Allograft Rejection [ Time Frame: from day 1 to 24 months post operation ]

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2. Primary:

Rejection Day of Onset [ Time Frame: From day 1 to 2 years post operation ]

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3. Primary:

Rise in Serum Creatineine Above Posttransplant Nadir [ Time Frame: 24-32 days post operation ]

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4. Secondary:

Creatinine Level at 6 Month Post Operation [ Time Frame: 6 month post operation ]

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5. Secondary:

Creatinine Level at Year 1 Post Operation [ Time Frame: 1 year post operation ]

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6. Secondary:

Creatinine at 2 Years [ Time Frame: 2 years post operation ]

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7. Secondary:

Monocyte Count [ Time Frame: 4 day post operation ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Alan Kirk
Organization: NIDDK, NIH
phone: NA
e-mail: allank@intra.niddk.nih.gov

Publications:

Santiago-Delpin EA. Trends in kidney transplantation in the United States. Transplant Proc. 1998 Sep;30(6):2867-8. No abstract available.

Responsible Party:	Allan D. Kirk, M.D../National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00001984 History of Changes
Other Study ID Numbers:	000013, 00-DK-0013
Study First Received:	January 26, 2000
Results First Received:	September 13, 2010
Last Updated:	September 13, 2010
Health Authority:	United States: Federal Government