Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation
Condition: Kidney Failure, Chronic; Kidney Transplantation; Immunosuppression
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Improvements in surgical techniques, donor selection, immunosuppression practices, and the
      enhanced experience of specialized pediatric transplant teams have all led to marked
      improvements in patient and kidney graft survival in infants and young children Long-term
      graft survival rates decrease in adolescents 11 to 17 years of age. Several studies have
      suggested this decrease may be the result of noncompliance with immunosuppressive medications
      in this age group. Therefore, protocols that minimize the use of immunosuppressive
      medications, while retaining kidney function are necessary for improving graft and patient
      survival in children. The purpose of this study is to determine the safety of sirolimus
      monotherapy for long-term immunosuppression in children and adolescents after kidney
      transplantation.

      This study will enroll 10 participants who previously completed the CCTPT-PC01 study. The
      accrual period is scheduled for 12 months. The study follow-up period will last 96 weeks.
      Patients from the CCTPT-PC01 study have been maintained on sirolimus and mycophenolate
      mofetil (MMF) since 2-3 months post transplant. Enrolled participants receiving (MMF) or
      Azathioprine at study entry will have their doses withdrawn gradually over a period of 6
      months. Dosage will be reduced by 25% initially and by 25% every 2 months resulting in
      complete withdrawal by 6 months.

      This study will consist of 11 study visits after screening and study entry. Study visits will
      occur at weeks 1, 8, 16, 24, 32, 40, 48, 60, 72, 84, and 96. A physical exam, vital signs,
      sirolimus levels, as well as blood and urine collection will occur at all visits. A renal
      biopsy will be performed at week 96.
    

Intervention name(s): Sirolimus; MMF or Azathioprine
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets or liquid taken every 12 hours. Dosage adjusted to attain target trough levels of 8-12 ng/mL. Participants who have maintained such levels at study entry on once daily dosage will be permitted to continue on once daily dosing.; 600 mg/m2 MMF taken orally daily or Azathioprine orally daily. Dosage of Azathioprine is dependent on weight. MMF or Azathioprine will be reduced by 25% initially and by 25% every 2 months resulting in complete withdrawal by 6 months.
Other intervention name(s): Rapamycin, Rapamune
Intervention MeSH terms: Sirolimus; Azathioprine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: End stage renal disease; Kidney transplantation; Renal transplantation; Kidney failure; Children; Adolescents; Sirolimus; Rapamycin; CellCept; Mycophenolate mofetil (MMF); Azathioprine