Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Intervention: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone; Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone
Intervention description: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.
1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses
3°day: Prednisone 2 mg/kg/d in 2 doses
4ºday: Prednisone 1 mg/kg/d in 2 doses
5ºday: Prednisone 0.5 mg/kg/d in 2 doses
6ºday: Prednisone 0.25 mg/kg/d in 2 doses
7ºday: Stop Prednisone; Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day
10°days after Tx: 2 mg/kg/d
Day 11 - 20: 1 mg/kg/d
Day 21 - 30: 0.5 mg/kg/d
Day 31 - 60: 0.3 mg/k/d
Week 8 - 12: 0.25 mg/k/d
Week 12 - 16: 0.20 mg/k/d
Week 16 - 20: 0.15 mg/k/d
Month 6 - 12: 0.10 - 0.12 mg/k/d
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Prednisolone; Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 1 Year
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Pediatric renal transplantation,Bone metabolism (DXA-pQCT); mRNAFOXP3/IL-17,Steroid withdrawal

Summary:

      The present study investigates the safety and efficacy of steroid withdrawal at six days
      post-transplant in pediatric renal recipients under concomitant immunosuppression based on
      antibodies anti IL2 (interleukin 2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF). To
      investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and
      evaluate the expression of IL17 (interleukin 17) and mRNA FOXP3 (messenger ribonucleic acid
      forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy).

      Hypothesis:Steroid withdrawal in renal pediatric transplant patients improves growth and bone
      metabolism without increasing the risk of acute rejection. The expression of FoxP3/IL17 in
      urine cells could be an early molecular markers of acute rejection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 16.0 years

          -  Bone age of boys < 15 years, of girls < 13 years

          -  Prepuberal Tanner Status I

          -  First or second kidney transplant, living or deceased kidney donation

          -  Immunosuppression with Tacrolimus (TAC),Mycophenolate mofetil (MMF)

          -  Patients and parents, respectively, have given their written consent after
             enlightenment (informed consent)

        Exclusion Criteria:

          -  Irreversible rejection of former transplant

          -  Highly reactive (> 30%) lymphocytotoxic antibodies within 12 months prior to
             transplantation

          -  Suspected insufficient medication compliance in dialysis

          -  Patients receiving a basic immunosuppression other than that prescribed in this
             protocol

          -  Simultaneous therapy with growth hormone after renal transplant