NCT06283589 is a Phase 1 clinical trial of INZ-701 in Calciphylaxis, sponsored by Inozyme Pharma.

Who is sponsoring NCT06283589?

NCT06283589 is sponsored by Inozyme Pharma.

What drugs are being tested in NCT06283589?

Interventions in NCT06283589: INZ-701.

What condition does NCT06283589 study?

NCT06283589 studies Calciphylaxis.

Is NCT06283589 still recruiting?

NCT06283589 is currently completed. Last updated 5 February 2025.

Last reviewed 2025-02-05 · How we verify

NCT06283589

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 Last updated 5 February 2025

What this trial tests

Phase 1 trial testing INZ-701 in Calciphylaxis in 11 participants. Completed in 13 December 2024.

Timeline

12 February 2024

Primary endpoint
27 July 2024

13 December 2024

Quick facts

Lead sponsor	Inozyme Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	12 February 2024
Primary completion	27 July 2024
Estimated completion	13 December 2024
Sites	2 locations across United States

Drugs / interventions tested

INZ-701 — full drug profile →

Conditions studied

Calciphylaxis — all drugs for Calciphylaxis →

Sponsor

Inozyme Pharma — full company profile →

Who can join

Adults 18 to 69, any sex, with Calciphylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

ENPP1 enzyme replacement therapy improves ectopic calcification but does not rescue skeletal phenotype in a mouse model for craniometaphyseal dysplasia.
Reichenberger EJ, O'Brien K, Hatori A, Carpenter TO, et al · · 2024 · cited 4× · PMID 39165910 · DOI 10.1093/jbmrpl/ziae103
Calciphylaxis diagnosis, management and future directions: a comprehensive update on behalf of the European Renal Association CKD-MBD Working Group.
Huish S, Moore S, Alfieri C, Bellasi A, et al · · 2025 · cited 3× · PMID 41367922 · DOI 10.1093/ckj/sfaf338
Generalized Arterial Calcification of Infancy (GACI): State of the Art and Clinical Perspectives.
Castaldi B, Imperatore G, Pomiato E, Di Salvo G. · · 2026 · PMID 42188070 · DOI 10.3390/jcdd13050184
Therapeutic approaches for the treatment of genetic and acquired cardiovascular calcification.
O'Brien K, Husson H, Sabbagh Y. · · 2025 · PMID 41126916 · DOI 10.3389/fcvm.2025.1636432

Verify or expand the search:

Other trials of INZ-701

Trials testing the same drug.

NCT07473973 — ENERGY 2: Evaluation of the Efficacy and Safety of INZ-701 in Infants With ENPP1 Deficiency · Phase 3 · recruiting
NCT06739980 — The ENABLE Study: Safety and Efficacy Study of INZ-701 in Patients With ENPP1 Deficiency · Phase 2 · withdrawn
NCT05734196 — The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency · Phase 1 · recruiting
NCT05030831 — Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ABCC6 Deficiency Causing PXE · Phase 1, PHASE2 · completed
NCT04686175 — Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ENPP1 Deficiency · Phase 1, PHASE2 · completed

Other recruiting trials for Calciphylaxis

Currently open trials in the same condition.

NCT04592640 — Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis · EARLY_PHASE1 · recruiting
NCT06065852 — National Registry of Rare Kidney Diseases · recruiting

Other Inozyme Pharma trials

Trials by the same sponsor.

NCT07473973 — ENERGY 2: Evaluation of the Efficacy and Safety of INZ-701 in Infants With ENPP1 Deficiency · Phase 3 · recruiting
NCT06739980 — The ENABLE Study: Safety and Efficacy Study of INZ-701 in Patients With ENPP1 Deficiency · Phase 2 · withdrawn
NCT05734196 — The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency · Phase 1 · recruiting
NCT05050669 — Natural History Study of ENPP1 Deficiency and the Early-onset Form of ABCC6 Deficiency · completed
NCT05030831 — Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ABCC6 Deficiency Causing PXE · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06283589 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inozyme Pharma
Last refreshed: 5 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06283589.

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