Trials / Withdrawn
WithdrawnNCT04627831
Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography
Randomized Parallel Group Study Comparing the Renal Safety of CAPTISOL-Enabled™ Iohexol (CE-Iohexol) Injection and Omnipaque™ (Iohexol) Injection in Patients With Impaired Renal Function Undergoing Coronary Angiography
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Ligand Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Randomized parallel group study comparing the renal safety of Captisol-Enabled™ Iohexol (CE-Iohexol) Injection and Omnipaque™ (Iohexol) Injection in patients with impaired renal function undergoing coronary angiography.
Detailed description
The purpose of this trial is to demonstrate a reduction in the incidence of contrast-induced acute kidney injury (CI-AKI), also known as contrast-induced nephropathy (CIN), and the equivalence of image quality following administration of Captisol-Enabled™-Iohexol (CE-Iohexol) Injection compared to Omnipaque™(Iohexol) Injection in patients with impaired renal function undergoing invasive coronary angiography.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CE-Iohexol | Captisol-Enabled™ Iohexol as needed for the diagnostic procedure. Volume will be determined according to medical need. |
| DRUG | Iohexol | Iohexol as needed for the diagnostic procedure. Volume will be determined according to medical need. |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2023-03-01
- Completion
- 2023-04-01
- First posted
- 2020-11-13
- Last updated
- 2022-04-11
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04627831. Inclusion in this directory is not an endorsement.