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NCT06283589 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Inozyme Pharma.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target

NCT06283589: Completed Phase 1 study, sponsored by Inozyme Pharma.

NCT06283589 is a Phase 1 study that has completed, run by Inozyme Pharma. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06283589, a Phase 1 study, has completed, sponsored by Inozyme Pharma.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Change from baseline in pre-hemodialysis plasma inorganic pyrophosphate concentrations throughout the study.

Interventions

  • DRUG INZ-701

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2024-02-12
Est. Completion 2024-12-13
Phase Phase 1
Inozyme Pharma

9 total trials

What the finished NCT06283589 record still lists

NCT06283589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 1 intervention - of which INZ-701 is the first listed.

NCT06283589 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06283589 about?

NCT06283589 is a clinical study titled "The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis". 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...

What is the current status of trial NCT06283589?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2024-02-12. Estimated completion is 2024-12-13.

What interventions are being tested in trial NCT06283589?

The interventions under investigation include: INZ-701 (DRUG).

Who is sponsoring clinical trial NCT06283589?

This trial is sponsored by Inozyme Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06283589's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06283589, the US trial registry maintained by the National Library of Medicine. NCT06283589 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.