Disorder Related to Renal Transplantation Clinical Trial
Official title:
Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
Verified date | August 2020 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
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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