A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)

PHASE4CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

April 30, 2003

Primary Completion Date

January 31, 2006

Study Completion Date

January 31, 2006

Conditions
Kidney Transplantation
Interventions
BIOLOGICAL

DT

Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response.

DRUG

Daclizumab

The fifth dose (1 milligram per kilogram \[mg/kg\]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).

BIOLOGICAL

KLH

KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.

Trial Locations (5)

46202

Indianapolis

64108

Kansas City

97201

Portland

90027-6062

Los Angeles

90095-1752

Los Angeles

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02576145 - A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax) | Biotech Hunter | Biotech Hunter