Trial record 2 of 16 for:    CMV and Utah

A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Astellas Pharma Inc
Sponsor:
Collaborator:
Vical
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01974206
First received: October 28, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.


Condition Intervention Phase
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
Biological: ASP0113
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of first cytomegalovirus (CMV) viremia [ Time Frame: One year post first study drug administration ] [ Designated as safety issue: No ]
    Defined as plasma viral load of ≥ 1000 IU/mL by central assay


Secondary Outcome Measures:
  • Incidence of adjudicated CMV-associated disease, including CMV syndrome and CMV tissue-invasive disease [ Time Frame: One year post first study drug administration ] [ Designated as safety issue: No ]
  • Incidence of CMV viremia by central assay [ Time Frame: One year post first study drug administration ] [ Designated as safety issue: No ]
    Defined as plasma viral load ≥ the lower limit of quantification [LLOQ] by central assay

  • Incidence of adjudicated CMV-specific antiviral therapy for the treatment of CMV viremia or disease [ Time Frame: One year post first study drug administration ] [ Designated as safety issue: No ]
  • Graft Survival [ Time Frame: One year post first study drug injection ] [ Designated as safety issue: No ]
    Defined as any subject that does not fit the definition of graft loss as follows: graft loss is defined as subject death; re-transplant, nephrectomy; or return to permanent dialysis

  • Subject Survival [ Time Frame: One year post first study drug injection ] [ Designated as safety issue: No ]
    Defined as any subject that is known to be alive


Estimated Enrollment: 140
Study Start Date: November 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP0113 Biological: ASP0113
intramuscular injection
Placebo Comparator: Placebo Drug: Placebo
intramuscular injection

Detailed Description:

Subjects will be followed for one year after first study drug injection. This is the primary study period.

Subjects will be followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CMV negative subject having received a CMV seropositive kidney (living or deceased)
  • Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through Randomization.

Exclusion Criteria:

  • Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
  • Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.
  • Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974206

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Vical
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01974206     History of Changes
Other Study ID Numbers: 0113-CL-2001, 2013-000464-29
Study First Received: October 28, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Australia: Human Research Ethics Committee

Keywords provided by Astellas Pharma Inc:
ASP0113
Cytomegalovirus (CMV)
Kidney Transplantation

ClinicalTrials.gov processed this record on July 26, 2014