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WITHDRAWNPHASE2

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

NCT04627831•Ligand Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female aged ≥18 years
•2. Referred for a coronary angiography (with or without percutaneous coronary intervention) and must meet either 1 of the following criteria:
•1. Estimated glomerular filtration rate (eGFR) \<45 and ≥15 mL/min/1.73 m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation; or
•2. eGFR \<60 and ≥45 mL/min/1.73 m2 as determined by the CKD-EPI equation and at least 1 of the following conditions:
•* Age \>75 years
•* Diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤10%
•* New York Heart Association (NYHA) class II or III heart failure
•* Albuminuria with urine albumin-to-creatinine ratio (UACR) or urine protein-to- creatinine ratio (UPCR) ≥300 and ≤4000 mg/g; or
•* Anemia, with hemoglobin levels ≥8 g/dL but \<12.0 g/dL in women and \<13.0 g/dL in men, as defined by the World Health Organization
•3. If female, must also meet any 1 of the following criteria:
+8 more criteria

Exclusion Criteria

•1. eGFR \<15 mL/min/1.73 m2
•2. Reduction in eGFR by approximately 25% that is considered to be acute per the Investigator's judgment
•3. Body weight \>125 kg
•4. Uncorrected clinically significant abnormalities of clinical laboratory assessments which, in the Investigator's opinion, will interfere with the study conduct, including but not limited to the following:
•1. HbA1c \>10%
•2. Blood glucose \>270 mg/dL
•3. Hemoglobin \<8 g/dL
•4. Albuminuria with UACR or UPCR \>4000 mg/g; or
•5. Aspartate aminotransferase or alanine aminotransferase \>3 x upper limit of reference range
•5. Positive test for severe acute respiratory syndrome coronavirus 2 RNA at Screening;
+12 more criteria

Key Dates

Start Date

January 1, 2022

Primary Completion Date

March 1, 2023

Completion Date

April 1, 2023

Last Updated

April 11, 2022

Conditions

Contrast-induced Nephropathy

Interventions

CE-Iohexol

DRUG

Iohexol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography

Inclusion Criteria

Exclusion Criteria

Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.

Clinical Validation of the RENISCHEM L-FABP POC Assay

Contrast Nephropathy Associated FFA

Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans

Role of Amlodipine in Reduction of CIN

Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients