E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Kidney Graft Dysfunction |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of 'reperfusion injury' (tissue damage) occurring within the first few days of transplantation with a consequential lack of proper functioning of the transplanted kidney. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051366 |
E.1.2 | Term | Kidney graft dysfunction |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess out to one-year the clinical status of patients who completed the double-blind part A or 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
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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• Withdrawn from OPN305-102 prior to the 6 month final visit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
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E.5 End points |
E.5.1 | Primary end point(s) |
• Incidence of allograft biopsy-proven rejection or 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
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E.5.1.1 | 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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E.5.2 | Secondary end point(s) |
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Belgium |
Czech Republic |
France |
Germany |
Netherlands |
Poland |
Spain |
Switzerland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |