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NCT00683553 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Safety Study of I5NP to Prevent Acute Kidney Injury (AKI) in Patients at High Risk of AKI Undergoing Major Cardiovascular Surgery (QRK.004)
A Phase 1 study, sponsored by Quark Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00683553 is a Phase 1 study that was terminated before completion, run by Quark Pharmaceuticals. The registered enrollment target is 3 participants.
The verdict
NCT00683553, a Phase 1 study, was terminated before completion, sponsored by Quark Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 10 sites in the United States. Up to 48 patients at high risk for AKI (CCF score ≥ 5 OR an estimated GFR (eGFR) \<60 mL/min/1.73 m2) who have undergone major cardiovascular surgery will participate. Patients will receive a single IV injection of I5NP or placebo following cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal of the cardiopulmonary bypass machine (CBM). The duration of the study is approximately 44 days, inclusive of a 14 day screening period. Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 - 5 and Day 7 or hospital discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be made at 6 and 12 months after date of surgery.
Interventions
- DRUG Placebo
- DRUG I5NP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00683553
The ClinicalTrials.gov registry entry for NCT00683553 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 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 Placebo is the first listed.
NCT00683553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00683553 about?
NCT00683553 is a clinical study titled "A Dose Escalation and Safety Study of I5NP to Prevent Acute Kidney Injury (AKI) in Patients at High Risk of AKI Undergoing Major Cardiovascular Surgery (QRK.004)". This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 10 sites in the United States. Up to 48 patients at high risk for AKI (CCF score ≥ 5 OR an estimated GFR (eGFR) \<60 mL/min/1.73 m2) who have undergone major c...
What is the current status of trial NCT00683553?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2008-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00683553?
The interventions under investigation include: Placebo (DRUG), I5NP (DRUG).
Who is sponsoring clinical trial NCT00683553?
This trial is sponsored by Quark Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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