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

NCT02576145 | Completed Phase 4 Results DMC

• 1 other identifier: PA16215
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

Brief Summary

This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization

  Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).

  Baseline and Day 43 or Day 57

Secondary Outcomes (15)

• Number of Participants Who Developed a Positive Cellular Response to KLH Immunization

  Baseline, Day 22, Day 29, Day 43, and Day 57

• Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization

  Baseline, Day 22, Day 29, Day 43 and Day 57

• Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)

  Baseline, Day 22, Day 29, Day 43 and Day 57

• Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)

  Baseline, Day 22, Day 29, Day 43 and Day 57

• Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations

  Baseline, Day 22, Day 29, Day 43 and Day 57

Study Arms (2)

Group A (With Daclizumab Therapy)

EXPERIMENTAL

Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram \[mg/kg\]) with Day 1 vaccine administered immediately prior to the fifth dose.

Biological: DT; Drug: Daclizumab; Biological: KLH

Group B (Post Daclizumab Therapy)

ACTIVE COMPARATOR

Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.

Biological: DT; Biological: KLH

Interventions

DT BIOLOGICAL

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.

Group A (With Daclizumab Therapy); Group B (Post Daclizumab Therapy)

Daclizumab DRUG

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).

Also known as: Zenapax

Group A (With Daclizumab Therapy)

KLH BIOLOGICAL

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.

Group A (With Daclizumab Therapy); Group B (Post Daclizumab Therapy)

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary renal transplant recipients between 2 and 19 years of age
• Receiving or have received daclizumab in the previous 4-18 months
• Receiving or have received daclizumab less than (\<) 24 hours pretransplant and additional courses every other week
• Single organ recipients (kidney only)
• Previous vaccination with tetanus toxoid (TT) prior to transplant
• Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor, mycophenolate mofetil, and prednisone (or equivalent corticosteroid)

You may not qualify if:

• Received intravenous gamma globulin or a TT vaccination since transplant
• Experienced rejection within 3 months of receiving study vaccinations and/or treated with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection within 3 months of receiving study vaccinations
• Received any vaccine within 30 days of receiving study vaccinations
• Received plasmapheresis treatment or growth hormone treatment since transplant

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Unknown Facility

Los Angeles, California, 90027-6062, United States

Location

Unknown Facility

Los Angeles, California, 90095-1752, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

Kansas City, Missouri, 64108, United States

Location

Unknown Facility

Portland, Oregon, 97201, United States

Location

MeSH Terms

Interventions

Daclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 15, 2015
• Study Start: April 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: January 13, 2016
• Results First Posted: January 13, 2016

Record last verified: 2015-12

Locations

US (5)