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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00167661
Other study ID # 2011-0661
Secondary ID H-2003-0493A5367
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2004
Est. completion date May 2012

Study information

Verified date August 2020
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 33
Est. completion date May 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Months to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Disorder Related to Renal Transplantation

Intervention

Drug:
Campath-1H
two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant

Locations

Country Name City State
United States University of Wisconsin Hospital and Clinics Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Graft Rejection at 1, 3, 6, 12, and 24 months
Primary Participant Graft Survival at 6, 12, and 24 months
Secondary Estimated Glomerular Filtration Rate (EGFR) Measure of renal function at 1, 6, 12 and 24 months
Secondary Number of Participants With Infection Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK) up to 24 months
Secondary Number of Participants With Malignancy up to 24 months
Secondary Growth Post-transplant Reported by Height Z Score 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. up to 24 months
Secondary Number of Participants With Hypertension up to 24 months
Secondary Number of Participants With Hyperlipidemia up to 24 months
Secondary Participant Survival at 6, 12, and 24 months
Secondary Number of Participant With Diabetes Mellitus up to 24 months
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