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Contrast-induced NephropathyPhase 2NCT04627831

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

A Phase 2 study testing CE-Iohexol and Iohexol in people with Contrast-induced Nephropathy, run by Ligand Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Contrast-induced Nephropathy
What is being tested?
CE-Iohexol and Iohexol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2022to Apr 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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
  • 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

Who cannot join

  • 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
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  • 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
  • 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:
  • NYHA class IV or decompensated heart failure; or
  • 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

About this study

Official title: 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

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.

Read the 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.

Being tested
CE-Iohexol, Iohexol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CE-IohexolDrug

    Also called Captisol-Enabled™ Iohexol

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

  • IohexolDrug

    Also called Omnipaque™ (Iohexol)

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

Study groups in NCT04627831
Study groupRoleWhat they receive
CE-IohexolExperimentalSubject is randomized to receive CE-Iohexol Injection
Receives: Drug: CE-Iohexol
Omnipaque™ (Iohexol)Active comparatorSubject is randomized to receive Omnipaque™ Iohexol Injection
Receives: Drug: Iohexol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 7 days

Secondary outcomes (5)

  1. Image quality

    Compare image quality of coronary angiography in patients administered CE-iohexol versus iohexol.

    Measured: Day 1

  2. Change in serum creatinine (SCr)

    Evaluate the changes in SCr in patients administered CE-iohexol versus iohexol.

    Measured: 7 days

  3. Proportion of patients exhibiting an increase in SCr

    Evaluate the proportion of patients exhibiting an increase in SCr following intravascular administration of CE-iohexol compared with iohexol.

    Measured: 7 days

  4. Change in serum cystatin C

    Evaluate the changes in serum cystatin C in patients administered CE-iohexol versus iohexol.

    Measured: 7 days

  5. Incidence of Adverse Events

    The number of patients with adverse events (AE) and serious adverse events will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Monitoring for Major Adverse Cardiac and Renal Events (MARCEs) will be part of the AE assessment.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study startJan 2022 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionApr 2023 (estimated)

Why it stopped: Internal decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627831
Sponsor's protocol ID
CE-Iohexol - Study 201
Other IDs
Ligand 201, CAP201
Status last verified
Feb 2021
First submitted
27 Oct 2020
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CE-Iohexol and Iohexol in people with Contrast-induced Nephropathy, run by Ligand Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of contrast-induced acute kidney injury (CI-AKI) (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04627831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.

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