Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

Disorder Related to Renal Transplantation Clinical Trial

Official title:

Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

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
• 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
• 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

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