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

NCT06283589 | Completed Phase 1 FDA Drug

• 1 other identifier: INZ701-401
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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.

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); chronic kidney disease (CKD); calcinosis

Outcome Measures

Primary Outcomes (1)

• Determine if INZ-701 increases PPi levels

  For each participant, plasma PPi will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time to determine if there's been a change.

  26 days (Treatment Period)

Secondary Outcomes (5)

• Assess the Time to Maximum Serum Concentration (Tmax)

  26 days (Treatment Period)

• Assess the Maximum Serum Concentration (Cmax) of INZ-701

  26 days (Treatment Period)

• Assess the Area under the concentration-time curve over the dosing interval (AUCtau)

  26 days (Treatment Period)

• Assess the Clearance after extravascular administration of drug (CL/F)

  26 days (Treatment Period)

• Assess ENPP1 Activity

  26 days (Treatment Period)

Study Arms (1)

INZ-701

EXPERIMENTAL

The study consists of a 26-day treatment period where the dose of INZ-701 will be 1.8 mg/kg once weekly. INZ-701 will be administered as a subcutaneous injection once weekly for 4 weeks on Days 3, 10, 17, and 24. The study participant's post-hemodialysis body weight on Day 1 will be used to calculate the dose to be administered.

Drug: INZ-701

Interventions

INZ-701 DRUG

Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.

Also known as: (rhENPP1-Fc).

INZ-701

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Inozyme Pharma: lead

Study Sites (2)

South Florida Nephrology Research

Coral Springs, Florida, 33071, United States

Location

Elixia Health

Hollywood, Florida, 33024, United States

Location

MeSH Terms

Conditions

Calciphylaxis; Calcinosis Cutis; Calcinosis; Calcium Metabolism Disorders; Vascular Calcification; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kurt Gunter, MD

  Inozyme Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The SEAPORT 1 (INZ701-401) study is a Phase 1, open-label, multi-center study to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of INZ-701, given once per week over 4 weeks, in study participants with end-stage kidney disease undergoing hemodialysis.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: February 12, 2024
• Primary Completion: July 27, 2024
• Study Completion: December 13, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

US (2)