The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis

Completed · Phase 1

Conditions studied: Calciphylaxis

In brief

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.

Key facts

Study ID

NCT06283589

Run by

Inozyme Pharma

People needed

11

Starts

2024-02-12

Expected to finish

2024-12-13

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals meeting the following inclusion criteria may participate:
• 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.
• Males who are sexually active must agree to use condoms from the time of the first INZ-701 dose to 30 days after the last dose. Males must also agree to not donate sperm from the time of the first INZ-701 dose to 30 days after the last dose.
• In the opinion of the Investigator, study participants are able and willing to complete all study procedures per protocol.

You may not qualify if…

• Individuals meeting any of the following exclusion criteria may not participate:
• 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
• Weight >125 kg
• Concurrent participation in another interventional clinical study and/or receipt of any other investigational new drug within 5 half-lives of the last dose of the other investigational product or from 4 weeks prior to the first dose of INZ-701, whichever is longer, or use of an investigational device, through completion of participation in the study

Where it is running

• South Florida Nephrology Research — Coral Springs, Florida, United States
• Elixia Health — Hollywood, Florida, United States

Full record on ClinicalTrials.gov

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