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NCT00802347 · ClinicalTrials.gov registry record · Phase 1
I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation
A Phase 1 study, sponsored by Quark Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 374
- Enrollment target
NCT00802347 is a Phase 1 study that has completed, run by Quark Pharmaceuticals. The registered enrollment target is 374 participants.
The verdict
NCT00802347, a Phase 1 study, has completed, sponsored by Quark Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 374 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I /II study, patients who are undergoing renal transplantation with organs from DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be used to identify doses of I5NP to be used in follow-on efficacy studies. Part A will be a randomized, dose escalation study to determine the highest or maximum tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts 1-4). Part B will utilize the dose identified in Part A to further evaluate, in a double-blind manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo.
Interventions
- DRUG Saline
- DRUG I5NP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2008-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802347
The ClinicalTrials.gov registry entry for NCT00802347 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 374 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quark Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00802347 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00802347 about?
NCT00802347 is a clinical study titled "I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation". The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I /II study, patients who are undergoing renal transplantation with organs from DCD donors, ECD donor...
What is the current status of trial NCT00802347?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 374 participants. The study started on 2008-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00802347?
The interventions under investigation include: Saline (DRUG), I5NP (DRUG).
Who is sponsoring clinical trial NCT00802347?
This trial is sponsored by Quark Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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