Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Kidney transplantation is widely considered to be the treatment of choice for children with End Stage Renal Disease (ESRD). The purpose of this study is to determine the safety of sirolimus monotherapy for long-term immunosuppression in children and adolescents after kidney transplantation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Azathioprine; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Participant and/or parent guardian able to understand and willing to provide informed consent

• Previously enrolled and completed the CCTPT-PC01 study and within the 36 months post-completion timeframe prior to study entry

• Currently receiving sirolimus and MMF or azathioprine therapy

• No history of acute rejection episodes

• No evidence of acute or chronic rejection on the 24 month CCTPT-PC01 protocol biopsy or any subsequent biopsy obtained after that time prior to study entry

• PRA (Class I and II) less than 5% at study entry

• No evidence of donor specific antibody at study entry

• Stable renal function with GFR greater than 60 cc/min 1.73M^2 using the Schwartz calculated method

• A negative pregnancy test for female participants of childbearing potential at study entry

• Agreement by female and male participants to use FDA approved methods of contraception.

Exclusion Criteria:

• Total lymphocyte count less than 400 mm^3

• Acute or chronic infection at study entry

• Treatment with investigational drug within 1 month prior to study entry

• Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study

• History of allergic reaction to Iodine GFR assay

• History of malignancy within the past 12 months

• Inability or unwillingness to give informed consent or comply with the study protocol