A 6 month 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

Follow-up Protocol to the Open-Label Phase 0 Part of the Phase II Opsona Study OPN-305-102 (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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005768-90-DE

Enrollment

Registered

2013-03-14

Start date

2013-04-08

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Delayed Graft Function (DGF) following renal transplantation MedDRA version: 14.1 Level: LLT Classification code 10048747 Term: Renal graft function delayed System Organ Class: 100000004863

Interventions

Product Name: OPN-305 10mg/ml sterile solution Product Code: OPN-305 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not available Current Sponsor code: OPN-305 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Refusal to give written informed consent - Withdrawn from OPN-305-102 prior to the 28-day final visit - Plan to be included into another interventional investigational study

Design outcomes

Primary

Measure	Time frame
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 recording the following: - Occurrence of allograft rejection or loss - Occurrence of serious adverse events (SAEs) - Occurrence of infections by type and actual organism - Number of hospitalisations;Secondary Objective: No Secondary Objectives;Primary end point(s): - Occurrence of allograft rejection or loss - Occurrence of serious adverse events (SAEs) - Occurrence of infections by type and actual organism - Number of hospitalisations;Timepoint(s) of evaluation of this end point: 12 months after study drug administration in OPN-305-102.	—

Measure

Time frame

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 recording the following: - Occurrence of allograft rejection or loss - Occurrence of serious adverse events (SAEs) - Occurrence of infections by type and actual organism - Number of hospitalisations;Secondary Objective: No Secondary Objectives;Primary end point(s): - Occurrence of allograft rejection or loss - Occurrence of serious adverse events (SAEs) - Occurrence of infections by type and actual organism - Number of hospitalisations;Timepoint(s) of evaluation of this end point: 12 months after study drug administration in OPN-305-102.

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not Applicable	—

Countries

Belgium, Germany

Contacts

Public ContactVP Pharmaceutical Dev. & Operations

Opsona Therapeutics Ltd

mreilly@opsona.com+3531678 6170

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026