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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005767-27-CZ

Enrollment

400

Registered

2013-11-18

Start date

2014-01-09

Completion date

Unknown

Last updated

2016-01-18

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

Conditions

Prevention of Kidney Graft Dysfunction MedDRA version: 18.1 Level: LLT Classification code 10051366 Term: Kidney graft dysfunction 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 CAS Number: 1449294-76-1 Current Sponsor code: OPN-30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Completion of the double-blind part B of the 6-month study visit in the phase II trial (OPN305-102) • 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: • Refusal to give written informed consent • Withdrawn from OPN305-102 prior to the 6 month final visit • Plan to be included into another interventional investigational study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 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 (12 months from transplant) based on a determination of serum creatinine, Cystatin C and symmetrical dimethylarginine (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 ;Secondary Objective: No secondary objectives;Primary end point(s): • Incidence of biospy-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 ;Timepoint(s) of evaluation of this end point: 3 months (Nine-Month Post-Treatment) and 6 months (Twelve-Month Post-Treatment) Follow-up Study Visits	—

Measure

Time frame

Main Objective: 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 (12 months from transplant) based on a determination of serum creatinine, Cystatin C and symmetrical dimethylarginine (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 ;Secondary Objective: No secondary objectives;Primary end point(s): • Incidence of biospy-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 ;Timepoint(s) of evaluation of this end point: 3 months (Nine-Month Post-Treatment) and 6 months (Twelve-Month Post-Treatment) Follow-up Study Visits

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: 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.	—

Measure

Time frame

Secondary end point(s): None;Timepoint(s) of evaluation of this end point: 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.

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Countries

Austria, Belgium, Czech Republic, France, Germany, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactVP Pharmaceutical Dev. & Operations

Opsona Therapeutics Ltd

mreilly@opsona.com+35316786170

Outcome results

None listed

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