Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography
NCT04627831 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-04-11
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.
Conditions
- Contrast-induced Nephropathy
Interventions
- 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.
Sponsors & Collaborators
-
CyDex Pharmaceuticals, Inc.
collaborator INDUSTRY -
Ligand Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Keith Marschke, PhD · Ligand Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-31
- Primary Completion
- 2023-03-31
- Completion
- 2023-04-30
- FDA Drug
- Yes
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