Can a protein boost help heal blood vessel damage in dialysis patients?

NCT ID NCT06283589

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called INZ-701 in adults with end-stage kidney disease who are on hemodialysis and have low levels of a natural substance called pyrophosphate, which helps prevent calcium buildup in blood vessels. The study aims to see if weekly injections of INZ-701 are safe and can raise pyrophosphate levels, potentially addressing a condition called calciphylaxis that causes painful skin and tissue damage. Participants receive the drug for four weeks, and researchers monitor its effects through blood tests and safety checks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INZ-701 (a recombinant fusion protein designed to restore low pyrophosphate levels)
What this could lead to
If successful, this could point toward a treatment that raises pyrophosphate levels and potentially eases or prevents calciphylaxis in dialysis patients.
What could go wrong
This is an early, small Phase 1 study focused on safety and dosing, not proof of benefit. The drug may not effectively raise pyrophosphate or improve symptoms, and side effects are still being explored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

11 people

The number who actually took part.

Started

Feb 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals meeting the following inclusion criteria may participate: 1. 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) 2. Have ESKD and are receiving HD treatment 3. Are compliant with receiving 3 treatments of HD per week with a functioning arteriovenous (AV) fistula, AV graft, or central venous catheter 4. PPi level \<700 nmol/L at Screening 5. Must be willing and able to comply with the diet prescribed by their treating physician and/or the Investigator 6. Male or female aged \>18 years to \<70 years 7. 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 8. 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. 9. 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. 10. In the opinion of the Investigator, study participants are able and willing to complete all study procedures per protocol. Exclusion Criteria: Individuals meeting any of the following exclusion criteria may not participate: 1. Study participants receiving other types of dialysis than HD (eg, peritoneal dialysis, hemodiafiltration) 2. Study participants who are hospitalized 3. 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 4. Malignancy within the last year, except non-melanoma skin cancers or cervical carcinoma in situ 5. Advanced liver disease manifesting as liver cirrhosis 6. Myocardial infarction, stroke, or congestive heart failure requiring hospitalization within the last 6 months 7. Known intolerance to INZ-701 or any of its excipients 8. Weight \>125 kg 9. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Elixia Health

    Hollywood, Florida, 33024, United States

  • South Florida Nephrology Research

    Coral Springs, Florida, 33071, United States

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