WithdrawnPhase 2

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

Stopped: Internal decision

0Started 2022-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:
✓. 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:
✓. 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

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:
✕. HbA1c \>10%
✕. Blood glucose \>270 mg/dL
✕. Hemoglobin \<8 g/dL
✕. Albuminuria with UACR or UPCR \>4000 mg/g; or

What they're measuring

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

Timeframe: 7 days

Trial details

NCT IDNCT04627831

SponsorLigand Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03

View on ClinicalTrials.gov More Contrast-induced Nephropathy trials