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

Ligand Pharmaceuticals

Status and phase

Withdrawn

Phase 2

Conditions

Contrast-induced Nephropathy

Treatments

Drug: CE-Iohexol

Drug: Iohexol

Study type

Interventional

Funder types

Industry

Identifiers

NCT04627831

CE-Iohexol - Study 201

CAP201 (Other Identifier)

Ligand 201 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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:
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
If female, must also meet any 1 of the following criteria:
1. Surgically sterile with bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy
2. Postmenopausal with amenorrhea for at least 1 year and follicle-stimulating hormone in the postmenopausal range; or
3. 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:
1. 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
2. Willing to refrain from sperm donation from Day 1 until at least 90 days after investigational contrast agent administration
Willing to undergo protocol-recommended blood and urine collections, physical examinations, and laboratory investigations; and
Willing and able to provide written informed consent

Exclusion criteria

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:
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
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
Known allergy to heparin, history of heparin-induced thrombocytopenia, or history of heparin induced thrombocytopenia with thrombosis
Chronic disease(s) that, in the opinion of the Investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or would place the patient at undue risk by participating in the study, including but not limited to the following:
1. NYHA class IV or decompensated heart failure; or
2. Cirrhosis of the liver
Inability to receive periprocedural intravenous volume expansion
Received contrast media within 10 days prior to the scheduled coronary angiography
Unable or not willing to come off non-steroidal anti-inflammatory drugs, including ibuprofen, for at least 24 hours before the scheduled procedure