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A Study of RG7667 for the Prevention of Cytomegalovirus Disease in Kidney Transplant Recipients

This study is currently recruiting participants.
Verified May 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01753167
First received: December 17, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of RG7667 in cytomegalovirus (CMV)-negative recipients of a kidney transplant from a CMV-positive donor. Patients will be randomized into two treatment groups: RG7667 or placebo. The anticipated time on study drug is approximately 3 months.


Condition Intervention Phase
Cytomegalovirus Infections
 Drug: RG7667
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of RG7667 for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytomegalovirus (CMV) load as assessed by the central laboratory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cytomegalovirus load as assessed by the central laboratory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to detectable of CMV viremia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Viral load at first detection of CMV viremia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Peak viral load on or following first detection of CMV viremia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Initiation of preemptive antiviral therapy during the first 12 weeks after transplantation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Initiation of preemptive antiviral therapy during the first 24 weeks after transplantation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to initiation of first use of preemptive antiviral therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Duration of first use of preemptive antiviral therapy initiated during the first 12 weeks after transplantation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of all use of preemptive antiviral therapy initiated during the first 24 weeks after transplantation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • CMV disease (CMV syndrome or tissue-invasive disease) during the first 24 weeks after transplantation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in CMV serostatus as assessed by the central laboratory [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RG7667 Drug: RG7667
repeating doses of RG7667
Placebo Comparator: Placebo Arm Drug: Placebo
repeating doses of matching placebo to RG7667

  Eligibility

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

Inclusion Criteria:

  • Patient is scheduled to receive a primary or secondary renal allograft from a donor
  • Patient is seronegative for cytomegalovirus CMV and is receiving an allograft from a CMV-seropositive donor
  • Female patients of child-bearing age must have a negative pregnancy test at screening
  • Patients must use two adequate methods of contraception during the study and for a period of time after the study

Exclusion Criteria:

  • Patient is suspected of having CMV disease
  • Patient is receiving a multi-organ transplant
  • Active or chronic hepatic or hepatobiliary disease or elevations in a hepatic transaminase or bilirubin 2 upper limits of normal (ULN)
  • Active treatment for untreated tuberculosis or other infectious conditions that are significant in the judgment of the investigator
  • Infection with hepatitis B, hepatitis C or human immunodeficiency virus
  • Previous exposure to any investigational agent within 12 weeks or 5 half-lives
  • Any other acute or chronic condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the Principal Investigator, contraindicates the use of an investigational drug or that may affect the interpretation of the results or that renders the patient at high risk for treatment complications
  • History of alcoholism or substance abuse within 6 months before screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753167

Contacts
Contact: Reference Study ID Number: GV28418 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 40 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01753167     History of Changes
Other Study ID Numbers: GV28418, 2012-002245-37
Study First Received: December 17, 2012
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013