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

NCT04627831 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: CE-Iohexol - Study 201Ligand 201CAP201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast-induced acute kidney injury (CI-AKI)

  Evaluate the incidence of CI-AKI in patients with impaired renal function undergoing coronary angiography, from baseline to any blood draw within 7 days following intravascular administration of CE-iohexol compared with Omnipaque (iohexol).

  7 days

Secondary Outcomes (5)

• Image quality

  Day 1

• Change in serum creatinine (SCr)

  7 days

• Proportion of patients exhibiting an increase in SCr

  7 days

• Change in serum cystatin C

  7 days

• Incidence of Adverse Events

  30 days

Other Outcomes (1)

• Change in novel biomarkers of renal injury

  7 days

Study Arms (2)

CE-Iohexol

EXPERIMENTAL

Subject is randomized to receive CE-Iohexol Injection

Drug: CE-Iohexol

Omnipaque™ (Iohexol)

ACTIVE COMPARATOR

Subject is randomized to receive Omnipaque™ Iohexol Injection

Drug: Iohexol

Interventions

CE-Iohexol DRUG

Captisol-Enabled™ Iohexol as needed for the diagnostic procedure. Volume will be determined according to medical need.

Also known as: Captisol-Enabled™ Iohexol

CE-Iohexol

Iohexol DRUG

Iohexol as needed for the diagnostic procedure. Volume will be determined according to medical need.

Also known as: Omnipaque™ (Iohexol)

Omnipaque™ (Iohexol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 years
• Referred for a coronary angiography (with or without percutaneous coronary intervention) and must meet either 1 of the following criteria:
• 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
• 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
• If female, must also meet any 1 of the following criteria:
• Surgically sterile with bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy
• Postmenopausal with amenorrhea for at least 1 year and follicle-stimulating hormone in the postmenopausal range; or
• Is a woman of childbearing potential, non-pregnant and non-lactating at Screening, and must agree to use a protocol-recommended method of birth control or abstain from heterosexual intercourse, beginning at least 30 days prior to and until 30 days following investigational contrast agent administration
• If a male who can father a child, must also meet all of the following criteria:
• Willing to use a protocol-recommended method of birth control, ie, a double barrier approach (eg, condoms with spermicide) or abstain from heterosexual intercourse with women of childbearing potential, from Day 1 until at least 90 days after investigational contrast agent administration; and

You may not qualify if:

• eGFR \<15 mL/min/1.73 m2
• Reduction in eGFR by approximately 25% that is considered to be acute per the Investigator's judgment
• Body weight \>125 kg
• 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:
• HbA1c \>10%
• Blood glucose \>270 mg/dL
• Hemoglobin \<8 g/dL
• Albuminuria with UACR or UPCR \>4000 mg/g; or
• Aspartate aminotransferase or alanine aminotransferase \>3 x upper limit of reference range
• Positive test for severe acute respiratory syndrome coronavirus 2 RNA at Screening;
• Positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C virus RNA at Screening
• Uncontrolled hypertension, with systolic blood pressure (BP) \>180 mmHg or diastolic BP \>110 mmHg at Screening, based on the average of 3 BP measurements obtained from the patient's dominant arm
• Hypotension, that is considered to be of recent occurrence per the Investigator's judgment, and required resuscitation with intravenous fluids
• Non-cardiac acute illness or injuries that, in the opinion of the Investigator, could put the patient at risk or obscure the interpretation of the results of the study
• Known allergy or sensitivity to iodinated contrast agents, Captisol, or any of the excipients in the study contrast agent that cannot be adequately managed with prophylactic treatment per the Investigator's judgment and Good Clinical Practice

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead
• CyDex Pharmaceuticals, Inc.: collaborator

MeSH Terms

Interventions

Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Keith Marschke, PhD

  Ligand Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, and site personnel evaluating the subjects, will be blinded to the contrast media administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with impaired renal function scheduled for coronary angiography will be assessed for study eligibility. Prior to the planned coronary angiography procedure on Day 1, eligible patients will be randomized 1:1 to receive either CE-Iohexol Injection or iohexol. Randomization will be stratified by the following 2 factors. * Diabetes mellitus status: * Diabetics; or * Non-diabetics; and * Baseline eGFR, defined as the eGFR obtained as part of eligibility screening: * \<45 mL/min/1.73 m2; or * 45 mL/min/1.73 m2. Contrast volumes will be determined according to medical need. All subjects will be well hydrated before and after the examination, according to good clinical practice and institution's standard procedures.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 13, 2020
• Study Start: January 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2021-02