The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stag… (NCT06283589) | Clinical Trial Compass
CompletedPhase 1
The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis
United States11 participantsStarted 2024-02-12
Plain-language summary
The purpose of this study is to determine if multiple doses of INZ-701, given once per week over 4 weeks are safe and increase pyrophosphate (PPi) levels in hemodialysis-dependent (HD) end stage kidney disease (ESKD) study participants who have low PPi levels. In addition, the effect of hemodialysis on the pharmacokinetics of INZ-701 and PPi levels will be evaluated.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Study participants must provide written or electronic consent after the nature of the study has been explained, and prior to any research-related procedures, per International Council for Harmonisation (ICH) Good Clinical Practice (GCP)
. Have ESKD and are receiving HD treatment
. Are compliant with receiving 3 treatments of HD per week with a functioning arteriovenous (AV) fistula, AV graft, or central venous catheter
. PPi level \<700 nmol/L at Screening
. Must be willing and able to comply with the diet prescribed by their treating physician and/or the Investigator
. Male or female aged \>18 years to \<70 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since SEAPORT 1 was a Phase 1 trial focused on safety and tolerability of INZ-701 in hemodialysis patients, what do the early results tell us about whether it appeared safe enough to consider in future studies, and does that change any options for me?
2The trial was measuring whether INZ-701 raises PPi levels in the blood — can you explain why low PPi matters in calciphylaxis and whether restoring it is a promising approach for my specific situation?
3Now that this trial is completed, is there a next-phase study or follow-on trial I might be eligible for, given that Phase 1 results sometimes open the door to Phase 2 trials with more patients?
4Since calciphylaxis is a serious and difficult-to-treat condition, are there currently approved or standard treatments I should be pursuing right now while research like this is still in early stages?
5Given that this trial was specifically designed for adults with end-stage kidney disease on hemodialysis, how does my own kidney disease status and dialysis situation compare to what was studied, and is that relevant to any future treatment decisions?'
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Women of child-bearing potential (WOCBP) as defined in Clinical Trials Coordination Group (CTFG 2020) and provided in Appendix B, must have a negative serum pregnancy test at Screening and within 3 days of INZ-701 administration
. WOCBP and partners of fertile males who are WOCBP must be using or agree to use one highly effective form of contraception (per CTFG 2020) and a barrier method from at least 1 month before the first dose of INZ-701 to 30 days after the last dose (greater than 5 half-lives of INZ-701). WOCBP and partners of fertile males who are WOCBP must also agree to not donate ova from the time of the first INZ-701 dose to 30 days after the last dose.
Exclusion criteria
. Study participants receiving other types of dialysis than HD (eg, peritoneal dialysis, hemodiafiltration)
. Study participants who are hospitalized
. In the opinion of the Investigator, presence of any clinically significant disease or laboratory abnormality that may impact study participation and/or confound interpretation of the study results
. Malignancy within the last year, except non-melanoma skin cancers or cervical carcinoma in situ
. Advanced liver disease manifesting as liver cirrhosis
. Myocardial infarction, stroke, or congestive heart failure requiring hospitalization within the last 6 months
. Known intolerance to INZ-701 or any of its excipients