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 range18 Years – 69 Years
SexALL
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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
✓. 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)
✕. 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