Preventing kidney damage after heart surgery with ilofotase alfa
Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients At Risk for Renal Damage Following Open Heart Surgery
This study is testing if a new drug called ilofotase alfa can help prevent kidney damage in patients who are at risk after having heart surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AM-Pharma Industry-sponsored |
| Locations | 1 site (Munich) |
| Trial ID | NCT06168799 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of ilofotase alfa, administered intravenously, in patients at risk for renal damage following open heart surgery. It is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial with two arms, where eligible patients will receive either ilofotase alfa or a placebo before and after their surgery. Participants will be monitored for efficacy, safety, and pharmacokinetics through daily follow-up visits for five days post-surgery, with additional assessments at Day 28 and Day 61. The study aims to determine if ilofotase alfa can effectively prevent renal complications in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for specific types of open chest cardiovascular surgeries with a risk of renal damage.
Not a fit: Patients with body weight less than or equal to 55 kg or those with known or suspected glomerulonephritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of kidney damage in patients undergoing open heart surgery.
How similar studies have performed: Other studies have explored similar interventions for preventing renal damage in surgical patients, but the specific use of ilofotase alfa in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB): 1. 1. combined valve and CABG surgery; 2. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch) 2. CABG with 3 or more distal anastomoses 3. Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2 4. Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter Post-menopausal females do not require contraception during the trial. 5. Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter The five most important Exclusion Criteria: 1. Body weight ≤55 kg 2. Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis 3. Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery 4. Known chronic liver disorder with Child-Pugh C classification 5. Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest
Where this trial is running
Munich
- Research site — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Pickkers, Prof, MD, PhD — Radboud University Medical Center
- Study coordinator: Hof
- Email: CSA-RD.phase2@am-pharma.com
- Phone: +31302289222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.