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

Calciphylaxis Clinical Trial

Official title:
The SEAPORT 1 Study: An Open-label Exploratory Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of INZ-701 in Study Participants With End-Stage Kidney Disease Undergoing Hemodialysis

Clinical Trial 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.

Clinical Trial Description

INZ-701 is an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) recombinant fusion protein in development for the treatment of calciphylaxis. The SEAPORT 1 (INZ701-401) Study is a Phase 1, open-label study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of INZ-701 in study participants aged >18 to < 70 years with HD-dependent ESKD. Anticipated enrollment in the study is up to 10 study participants. The purpose of this study is to determine if INZ-701 increases PPi levels, as well as assess the PK/ PD characteristics of INZ-701 in patients with clinically low PPi levels. The study will consist of a Screening Period lasting up to 30 days, a Treatment and Assessment Period lasting 26 days, an end of study (EOS) Visit 30 days after the last dose of INZ-701, and if necessary, a safety visit 60 days after the last dose of INZ-701. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06283589
Study type Interventional
Source Inozyme Pharma
Contact Inozyme Clinical Trial Information
Phone +1 857 330 4340
Email clinicaltrials@inozyme.com
Status Recruiting
Phase Phase 1
Start date February 12, 2024
Completion date September 30, 2024
View Details
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