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Suppressing the Immune System With or Without Steroids in Children Who Have Received Kidney Transplants

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma Inc
Hoffmann-La Roche
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00141037
First received: August 1, 2005
Last updated: August 16, 2012
Last verified: August 2012
History of Changes

August 1, 2005
August 16, 2012
November 2005
September 2006   (final data collection date for primary outcome measure)
  • Efficacy, as measured by the difference in the change of standardized height at 1 year [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • safety, as measured by the rate at 12 months of biopsy-proven acute rejection [ Time Frame: At 1 year ] [ Designated as safety issue: Yes ]
  • Efficacy, as measured by the difference in the change of standardized height at 1 year
  • safety, as measured by the rate at 12 months of biopsy-proven acute rejection
Complete list of historical versions of study NCT00141037 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Suppressing the Immune System With or Without Steroids in Children Who Have Received Kidney Transplants
A Randomized, Multi-Center Comparative Trial of Tacrolimus With Steroids and Standard Daclizumab Induction Versus a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol With Extended Daclizumab Induction in Pediatric Renal Transplantation

Over the last 40 years, corticosteroids have been an important part of drug regimens used to prevent organ rejection and maintain the immune health of people who have received organ transplants. Unfortunately, the negative physical effects of corticosteroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a corticosteroid-free treatment regimen for children and adolescents who have received kidney transplants.

Corticosteroids have been a cornerstone of immunosuppressive therapy for kidney transplantation for over 40 years. However, poor growth and bone loss caused by the use of corticosteroids are devastating to pediatric kidney recipients. The negative physical implications of corticosteroid use also greatly impacts patients' compliance to their prescribed corticosteroid-containing regimens. The development of a corticosteroid-free regimen for post-transplant pediatric patients is sorely needed. This study will evaluate the safety and efficacy of a corticosteroid-free treatment regimen in children and adolescents who have received kidney transplants, compared to a standard of care regimen including corticosteroids. Participants in this study will be pediatric patients with end-stage kidney disease who will undergo kidney transplantation at the start of the study.

Patients will participate in this study for 3 years. Participants will be randomly assigned to one of two groups. Group 1 patients will receive daclizumab, tacrolimus, mycophenolate mofetil (MMF), and prednisone. Group 1 patients will receive daclizumab prior to transplantation and at Weeks 2, 4, 6, and 8 after transplantation. Group 1 patients will receive prednisone at the time of transplantation and will undergo gradual prednisone tapering post-transplant. Group 2 patients will receive daclizumab, tacrolimus, MMF, but no prednisone. Group 2 patients will receive daclizumab prior to transplantation, at Weeks 2, 4, 6, 8, and 11, and at Months 4, 5 and 6 after transplantation. To prevent opportunistic infections, all patients will receive prophylactic medications beginning after transplantation.

There will be 23 study visits during the 3-year study. A physical exam, medication history, adverse events reporting, blood pressure readings, growth assessment, and blood collection will occur at most visits. At the time of transplantation, patients will have a kidney biopsy. Patients will also undergo cataract screening within 4 months of transplantation.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Diseases
  • Kidney Transplantation
  • Drug: Daclizumab

    Steroid based arm: 1 mg/kg per-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8

    Steroid-free arm: 2 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11, and months 4, 5, and 6

  • Drug: Mycophenolate mofetil
    Typically administered in 2-3 divided doses both before and after transplant, and generally given at least until week two. Exact dosage is per recommendation.
  • Drug: Prednisone
    Administered as 10 mg/kg before transplant. Following transplant, regimen is adjusted to 2mg/kg/day in subjects weighing <40 kg, or 1.5 mg/kg/day in subjects weighing >40 kg.
  • Drug: Tacrolimus
    For recipients older than 5 years it is administered orally before transplant at a dose of 0.1 mg/kg twice daily for living donor recipients, or 0.1 mg/kg once daily for cadaveric donor recipients. For recipients under 5 years, dosing will be 0.15 mg/kg twice daily for living donor recipients, or 0.15 mg/kg once daily for cadaveric donor recipients. Post-transplant the oral dose will be 0.07 mg/kg twice daily adjusted per recommendation to achieve target levels.
  • Experimental: Prednisone
    Subjects will undergo a treatment regimen that includes prednisone
    Interventions:
    • Drug: Daclizumab
    • Drug: Mycophenolate mofetil
    • Drug: Prednisone
    • Drug: Tacrolimus
  • Active Comparator: Non-prednisone
    Subjects will undergo a treatment regimen absent of prednisone
    Interventions:
    • Drug: Daclizumab
    • Drug: Mycophenolate mofetil
    • Drug: Tacrolimus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
Not Provided
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary recipient of a kidney transplant
  • Meets site-specific transplant criteria
  • Panel Reactive Antibody (PRA) of 20% or less
  • Willing to use acceptable forms of contraception
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Previous treatment with steroids within 6 months prior to transplantation
  • Received en-bloc kidney or other kidney that does not meet protocol-specified requirements
  • Received an organ from an HLA identical donor or a non-heart-beating donor
  • Received a solid organ other than a kidney
  • Received a bone marrow or hematopoietic stem cell transplant
  • Received a repeat kidney transplant
  • Currently receiving an investigational pharmacologic or biologic agent
  • HIV infected or infected with another immunodeficiency virus
  • Hypersensitivity to murine products or the study drugs or their formulations
  • Inability to measure height accurately
  • Pregnant or breastfeeding
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141037
DAIT SNS01
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • Astellas Pharma Inc
  • Hoffmann-La Roche
Study Chair: Minnie Sarwal, MD, PhD Stanford University
Principal Investigator: Oscar Salvatierra, MD Pediatric Kidney Transplant Program, Stanford University Medical Center, Stanford Hospital and Clinics
National Institute of Allergy and Infectious Diseases (NIAID)
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP