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NCT01794663 · ClinicalTrials.gov registry record · Phase 2
Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
A Phase 2 study, sponsored by Opsona Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 252
- Enrollment target
NCT01794663 is a Phase 2 study that has completed, run by Opsona Therapeutics. The registered enrollment target is 252 participants.
The verdict
NCT01794663, a Phase 2 study, has completed, sponsored by Opsona Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 252 participants
- Enrollment target
Study Summary
When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed in the first 7 days after the transplantation then this is known as delayed graft function or dDGF. Also delayed graft function that does not require dialysis but is present because the serum creatinine does not fall sufficiently is known as functional delayed graft function or fDGF. This problem is often due to an excessive inflammatory reaction to not having had a blood supply between the time of donation and transplant. OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be partly responsible for increasing the risk of this inflammation. It is hoped that the effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring. The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF as well as improving other measures of kidney function and the overall safety of the antibody. In the first part of the study, each patient received an Infusion of one of three possible doses of OPN-305 or a placebo and in the second part the most suitable dose of OPN-305 and a placebo would be used. The purpose of this second part of the study is to find out if a dose of OPN-305 which has already been tested in an earlier part of this study can prevent kidney graft dysfunction. For the purposes of this study, kidney function will be assessed using the composite of delayed graft function (dDGF) because dialysis is necessary in the first 7 days and functional delayed graft function that does not require dialysis but is present because the serum creatinine, a key measure of renal function, does not fall sufficiently (fDGF) in the first 7 days post-transplant. Protocol OPN305-103 follows out to 12
Interventions
- DRUG Placebo
- DRUG OPN-305
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01794663
The ClinicalTrials.gov registry entry for NCT01794663 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Opsona Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01794663 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01794663 about?
NCT01794663 is a clinical study titled "Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function". When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed i...
What is the current status of trial NCT01794663?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2012-10. Estimated completion is 2016-06-30.
What interventions are being tested in trial NCT01794663?
The interventions under investigation include: Placebo (DRUG), OPN-305 (DRUG).
Who is sponsoring clinical trial NCT01794663?
This trial is sponsored by Opsona Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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