Phase II Study in the Prevention of CMV

• Research type

  Research Study

• Full title

  A Phase II Randomized, Double-Blind, Placebo-Controlled Trial Of CMV5322A/MCMV3068A For The Prevention Of Cytomegalovirus Disease In High-Risk Kidney Allograft Recipients

• IRAS ID

  112440

• Contact name

  Paul Griffiths

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2012-002245-37

• Research summary

  Cytomegalovirus (CMV)-associated disease remains a significant cause of post-transplant complications despite the use of antiviral treatments. High risk patients are those where CMV is transmitted from a seropositive donor to an uninfected recipient (CMV seronegative). The use of antiviral agents dramatically decreases the incidence of CMV-associated disease during the early post-transplant period. However, these antivirals have significant side effects for the patients. Some transplant centres give antiviral drugs prophylactically to high-risk patients, whereas other centres follow a policy of pre-emptive therapy, giving treatment only when CMV is detected in the blood of individual patients. The current randomised controlled trial will be conducted in centres using pre-emptive therapy. This Phase 2, randomized, double-blind, placebo-controlled study will assess the safety and clinical activity of multiple IV of study drug. 110 patients will be randomized (in a 1:1 ratio) into two treatment groups (active study drug or placebo control). Both arms will be followed pre-emptively for the prevention of CMV. This trial will include male and female patients aged at least 18 years of age, who are CMV-seronegative and who have received a kidney transplant from a CMV-seropositive donor. CMV-seronegative patients on the transplant list will be consented for this study in the event that the identified donor is CMV seropositive. At the time of transplantation, patients eligible for enrolment will be randomized. All patients will receive a total of four doses of the study drug or placebo. Study drug administration will be at the time of transplantation, then 7 days, 4 weeks and 8 weeks after transplantation. The primary objectives of this study are to evaluate the safety and determine the clinical activity of multiple IV doses of the study drug given to CMV-seronegative patients following a kidney transplant from a CMV-seropositive donor.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0733

• Date of REC Opinion

  7 Nov 2012

• REC opinion

  Further Information Favourable Opinion