Can a protein boost help heal blood vessel damage in dialysis patients?
NCT ID NCT06283589
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 69 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Elixia Health
Hollywood, Florida, 33024, United States
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South Florida Nephrology Research
Coral Springs, Florida, 33071, United States
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Other studies related to the condition(s) this trial covers.
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