CalciphylaxisPhase 1SEAPORT 1NCT06283589
SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
A Phase 1 study testing INZ-701 in people with Calciphylaxis, run by Inozyme Pharma at 2 sites in United States.
Trial summary
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic pyrophosphate (PPi) levels. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Calciphylaxis
- What is being tested?
- INZ-701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2024to 13 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Florida Nephrology Research
Coral Springs, Florida, 33071
Elixia Health
Hollywood, Florida, 33024
About this study
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
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic pyrophosphate (PPi) levels. Participants received INZ-701 1.8 mg/kg subcutaneously once weekly for 4 weeks. The study assessed changes in plasma PPi levels, PK characteristics, ENPP1-Fc activity, safety, tolerability, and immunogenicity.
Read the detailed description
SEAPORT 1 was a Phase 1 open-label study conducted at two sites in the United States. Participants with ESKD receiving maintenance hemodialysis and with plasma PPi levels <700 nmol/L received INZ-701 1.8 mg/kg by subcutaneous injection on Days 3, 10, 17, and 24. The primary objective was to evaluate changes from baseline in plasma PPi concentrations. Secondary objectives evaluated PK and ENPP1-Fc activity. Safety assessments included adverse events, laboratory parameters, vital signs, ECGs, physical examinations, and anti-drug antibodies. Participants were followed for up to 12 months after last dose.
- Conditions
- Calciphylaxis
- Being tested
- INZ-701
- Keywords
- calcific uremic arteriolopathy, calcinosis cutis, calcification, calcium metabolism disorders, mineral bone disorder (MBD), fusion protein, vascular calcification, end stage renal disease (ESKD), chronic kidney disease (CKD), calcinosis
- Medical subject headings
- Calciphylaxis, Calcinosis Cutis, Calcinosis, Calcium Metabolism Disorders, Vascular Calcification, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INZ-701Drug
Also called (rhENPP1-Fc).
Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.
| Study group | Role | What they receive |
|---|---|---|
| INZ-701 | Experimental | Participants received INZ-701 1.8 mg/kg administered subcutaneously once weekly on Days 3, 10, 17, and 24. Receives: Drug: INZ-701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plasma Inorganic Pyrophosphate (PPi) Concentrations
Change from baseline in pre-hemodialysis plasma inorganic pyrophosphate concentrations throughout the study.
Measured: Baseline through Follow-up Period (up to 12 months)
Secondary outcomes (5)
Serum INZ-701 Concentrations
Observed serum concentration-time profile of INZ-701.
Measured: Day 1 to Day 26
Assess the Maximum Serum Concentration (Cmax) of INZ-701
For each participant, the maximum concentration of INZ-701 in the serum will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time.
Measured: 26 days (Treatment Period)
Assess the Area under the concentration-time curve over the dosing interval (AUCtau)
For each participant, variation of concentration of INZ-701 in the serum will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time.
Measured: 26 days (Treatment Period)
Assess the Clearance after extravascular administration of drug (CL/F)
For each participant, clearance of INZ-701 from the body will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time.
Measured: 26 days (Treatment Period)
Assess ENPP1 Activity
For each participant, ENPP1 activity is a measurement of INZ-701 activity in human serum using a chromogenic based method.
Measured: 26 days (Treatment Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start12 Feb 2024
- Primary completion27 Jul 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalciphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group assignment. All enrolled participants received INZ-701 1.8 mg/kg administered subcutaneously once weekly for 4 weeks. The study was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease and low plasma inorganic pyrophosphate (PPi) levels. No placebo or active comparator group was included.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inozyme Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioMarin Pharmaceutical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283589
- Sponsor's protocol ID
- INZ701-401
- Acronym
- SEAPORT 1
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to share any data as this product is still in development
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06283589
- Acronym / sponsor ID
- SEAPORT 1 / INZ701-401
- Conditions
- Calciphylaxis
- Keywords
- calcific uremic arteriolopathy, calcinosis cutis, calcification, calcium metabolism disorders, mineral bone disorder (MBD), fusion protein, vascular calcification, end stage renal disease (ESKD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Inozyme PharmaIndustry (pharma, biotech, devices)
- Collaborators
- BioMarin Pharmaceutical
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic pyrophosphate (PPi) levels. Participants received INZ-701 1.8 mg/kg subcutaneously once weekly for 4 weeks. The study assessed changes in plasma PPi levels, PK characteristics, ENPP1-Fc activity, safety, tolerability, and immunogenicity.
Detailed description
SEAPORT 1 was a Phase 1 open-label study conducted at two sites in the United States. Participants with ESKD receiving maintenance hemodialysis and with plasma PPi levels <700 nmol/L received INZ-701 1.8 mg/kg by subcutaneous injection on Days 3, 10, 17, and 24. The primary objective was to evaluate changes from baseline in plasma PPi concentrations. Secondary objectives evaluated PK and ENPP1-Fc activity. Safety assessments included adverse events, laboratory parameters, vital signs, ECGs, physical examinations, and anti-drug antibodies. Participants were followed for up to 12 months after last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group assignment. All enrolled participants received INZ-701 1.8 mg/kg administered subcutaneously once weekly for 4 weeks. The study was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease and low plasma inorganic pyrophosphate (PPi) levels. No placebo or active comparator group was included.
| Arm | Type | Receives |
|---|---|---|
| INZ-701 | Experimental | Drug: INZ-701Participants received INZ-701 1.8 mg/kg administered subcutaneously once weekly on Days 3, 10, 17, and 24. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INZ-701Also: (rhENPP1-Fc).Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody. | Drug | INZ-701 |
Primary outcome
Change From Baseline in Plasma Inorganic Pyrophosphate (PPi) Concentrations
Time frame: Baseline through Follow-up Period (up to 12 months)
Change from baseline in pre-hemodialysis plasma inorganic pyrophosphate concentrations throughout the study.
5 secondary outcomes
Serum INZ-701 Concentrations
Time frame: Day 1 to Day 26
Assess the Maximum Serum Concentration (Cmax) of INZ-701
Time frame: 26 days (Treatment Period)
Assess the Area under the concentration-time curve over the dosing interval (AUCtau)
Time frame: 26 days (Treatment Period)
Assess the Clearance after extravascular administration of drug (CL/F)
Time frame: 26 days (Treatment Period)
Assess ENPP1 Activity
Time frame: 26 days (Treatment Period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to share any data as this product is still in development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INZ-701 in people with Calciphylaxis, run by Inozyme Pharma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Plasma Inorganic Pyrophosphate (PPi) Concentrations (time frame: Baseline through Follow-up Period (up to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.