A Follow-Up study to the previous phase II clinical study (OPN-305-102) in kidney transplant patients who are at high risk of developing clinical complications, immediately post transplant, requiring renal dialysis, in order to assess the safety of OPN-305 and look at the number of infections, hopsitalisation and graft rejections in patients treated with OPN-305. This follow-up study is for the patients in Phase 0 of the earlier study

Phase 1

Conditions: Prevention of Delayed Graft Function (DGF) following renal transplantation
MedDRA version: 14.1Level: LLTClassification code 10048747Term: Renal graft function delayedSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2012-005768-90-BE

Lead Sponsor: Opsona Therapeutics Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 8

Inclusion Criteria

-Completion of the 28-day study visit in the open-label phase 0 of the phase II trial (OPN-305-102)
- Provide written informed consent for the follow-up protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Refusal to give written informed consent
- Withdrawn from OPN-305-102 prior to the 28-day final visit
- Plan to be included into another interventional investigational study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess out to one-year the clinical status of patients who completed the phase 0 part of the Opsona phase II protocol (OPN-305-102) by<br>recording the following:<br>- Occurrence of allograft rejection or loss<br>- Occurrence of serious adverse events (SAEs)<br>- Occurrence of infections by type and actual organism<br>- Number of hospitalisations;Secondary Objective: No Secondary Objectives;Primary end point(s): - Occurrence of allograft rejection or loss<br>- Occurrence of serious adverse events (SAEs)<br>- Occurrence of infections by type and actual organism<br>- Number of hospitalisations;Timepoint(s) of evaluation of this end point: 12 months after study drug administration in OPN-305-102.

Secondary Outcome Measures