Phase 2 N=130 Randomized Treatment

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

Kidney Diseases · Kidney Transplantation · Kidney Transplant · Renal Transplantation · Renal Transplant

Bottom Line

View on ClinicalTrials.gov: NCT00141037 ↗

Enrolled (actual)

130

Serious AEs

86.2%

Results posted

Jul 2013

Primary outcome: Primary: The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation — 0.37; 0.35 Standard Deviation Score (SDS) — p=0.79

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Daclizumab (Drug); Mycophenolate mofetil (MMF) (Drug); Prednisone (Drug); Tacrolimus (Drug); Ganciclovir (Drug); Valganciclovir (Drug); Trimethoprim and sulfamethoxazole (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Sep 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation	0.37; 0.35	0.79
PRIMARY Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation	18; 19	0.85

Summary

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

Eligibility Criteria

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 human leukocyte antigen (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
Human Immunodeficiency virus (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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00141037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.