Clinical trialNCT00141037CompletedPhase 1/PHASE2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment130Kidney DiseasesKidney TransplantKidney TransplantationRenal TransplantRenal Transplantation

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Minnie Sarwal, MD, PhD
California Pacific Medical Center
Study Chair
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Oscar Salvatierra, MD
Pediatric Kidney Transplant Program, Stanford University Medical Center, Stanford Hospital and Clinics
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama - Pediatric Nephrology
Birmingham, Alabama, United States
Maxine Dunitz Children'S Health Center Cedars-Sinai
Los Angeles, California, United States
Ucla - Department of Pediatrics, Division of Nephrology
Los Angeles, California, United States
Stanford University Medical Center, Lucile Packard Children'S Hospital
Palo Alto, California, United States
Ucsf Children'S Hospital
San Francisco, California, United States
University of Florida - Pediatric Nephrology
Gainesville, Florida, United States
Children'S Hospital of New Orleans-Department of Pediatric Nephrology
New Orleans, Louisiana, United States
Children'S Hospital Boston - Division of Nephrology
Boston, Massachusetts, United States
University of Michigan Medical Center, C.S. Mott Children'S Hospital- Division of Nephrology & Transplantation
Ann Arbor, Michigan, United States
Children'S Mercy Hospital - Department of Nephrology
Kansas City, Missouri, United States
the Children'S Hospital of Philadelphia-Department of Nephrology
Philadelphia, Pennsylvania, United States
Children'S Hospital & Regional Medical Center - Division of Nephrology
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DaclizumabGanciclovir →Mycophenolate mofetil →Prednisone →Tacrolimus →Sulfamethoxazole / trimethoprimValganciclovir →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2004
Primary completion: 30 Sept 2006
Completion: 30 Nov 2010
Last update posted: 29 Nov 2016
Registered enrollment: 130
Registry id: NCT00141037

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.