Follow-up Protocol to the Double-Blind Parts A and B of the Phase II Opsona Study OPN305-102 (A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function)

OPN-305 is a humanised IgG4 monoclonal antibody (MAb) against TLR2 that has
orphan medicinal product designation from the European Medicines Agency (EMA)
for prevention of Delayed Graft Function (DGF) following solid organ
transplantation. A similar designation has been granted by the Food & Drug
Administration in the USA in December 2011.

A multi-centre, randomised, double-blind, placebo-controlled, parallel-group,
sequential adaptive, phase II study to evaluate the safety, tolerability and
efficacy of OPN-305 in renal transplant patients at high risk of delayed graft
function (protocol OPN305-102) was initiated in November 2012. That study
includes safety and efficacy procedures and evaluations up to six months after
administration of OPN-305.

The current protocol (version 3) is a follow-up study, for patients from Part B
of study OPN305-102 who consent to participate out to 12 months following
OPN-305 or placebo administration, of the clinical status and graft function of
patients who participated in and completed the 6-month double-blind part B of
the phase II study described above.

To assess out to one-year the clinical status of patients who completed the
double-blind part B of the 6-month study period in the Opsona phase II protocol
(OPN305-102) by recording the following:
• Incidence of biopsy-proven allograft rejection or graft loss
• Initiation and frequency of dialysis or other renal replacement therapy (RRT)
• Estimated GFR at the end of the 6-month follow-up period based on a
determination of serum creatinine, Cystatin C and SDMA by the Central laboratory
• Incidence and type of serious adverse events (SAEs)
• The occurrence of infections by type and actual organism
• The incidence of hospitalisations

All patients entered in this follow-up study will attend a 3-month and 6-month
study visit corresponding to 9 and 12 months after their study-drug
administration in the initial phase II trial (OPN305-102). To indicate this
continuity the study visits will be described in this follow-up protocol as
being at 9 and 12 months following administration of OPN-305/placebo. Patients
will be informed that they have the right to withdraw from the study at any
time, without prejudice to their medical care, and are not obliged to state
their reasons. Any withdrawals must be fully documented and should be followed
up by the Investigator to complete an end-of-study evaluation if possible.

Schedule Of Assessments And Procedures: It is expected that patients will be
asked to give a written informed consent to participate in the follow-up study
at the completion (6-month) visit in the phase II study (OPN305-102) but a
window of 1 week is permitted to allow for any unforeseen circumstance(s).

Nine-Month Post-Treatment Follow-up Study Visit: If no routine or for-cause
visit is scheduled within 1 month either side of the 9-month post-treatment
visit then a study-specific visit must be scheduled for the patient to come to
the study site.

Twelve-Month Post-Treatment Follow-up Study Visit: If no routine or for-cause
visit is scheduled within 1 month either side of the 12-month post-treatment
visit then a study-specific visit must be scheduled for the patient to come to
the study site.

Other Visit(s): It is anticipated that patients will return to the study sites
for routine follow up visits and for cause. In the event such a visit occurs
within a month either side of the 9-month or 12-month post-treatment visit this
will be considered as the protocol visit for timing purposes. Where these
visits occur outside of the time window permitted for the 9- or 12-month visit
then the relevant CRFs will be completed for each visit.

Withdrawal: If a patient withdraws from the study the Investigator will try to
complete an end-of-study evaluation if the patient agrees.

not applicable