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INZ-701 for Calciphylaxis

Q: Which individuals meet the criteria for participation in this experimental endeavor?

Candidates aged between 18 and 69 years old with a diagnosis of calciphylaxis are eligible for inclusion in this study, which aims to enroll approximately 10 participants.

Q: Is it possible for patients to enroll in this ongoing clinical trial?

Per information from clinicaltrials.gov, this research trial is presently enrolling volunteers. The study was initially shared on February 12th, 2024, and the latest revision occurred on February 21st of the same year.

Q: What is the current number of individuals being recruited for participation in this research endeavor?

Indeed, information from clinicaltrials.gov confirms that this study is currently enrolling participants. It was first listed on February 12th, 2024, and the most recent update occurred on February 21st, 2024. The research aims to recruit a total of 10 individuals distributed across two distinct sites.

Q: Are individuals older than 65 years of age eligible to participate in this clinical trial?

Applicants eligible for this research study must be between 18 and 69 years old. There are a total of 45 studies catering to individuals under 18 years old, whereas there are 546 studies targeting patients over the age of 65.

Q: Has INZ-701 received approval from the FDA for clinical use?

In this Phase 1 investigation, INZ-701 has been assigned a safety rating of 1 by our team at Power due to the limited available data on its safety and effectiveness.

Phase 1

Recruiting

Research Sponsored by Inozyme Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have ESKD and are receiving HD treatment

Male or female aged >18 years to <70 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 days (treatment period)

Awards & highlights

Study Summary

This trial aims to see if giving multiple doses of INZ-701 once a week for 4 weeks is safe and can increase pyrophosphate levels in individuals with kidney disease. It will also look

Who is the study for?

This trial is for adults with end-stage kidney disease who are on hemodialysis. It's specifically aimed at those with low pyrophosphate levels, a condition that can lead to calciphylaxis—a rare but serious skin condition.Check my eligibility

What is being tested?

The study tests INZ-701, given weekly over a month, to see if it's safe and can raise pyrophosphate levels in patients. The trial also looks at how hemodialysis affects the drug and pyrophosphate in the body.See study design

What are the potential side effects?

Since this summary doesn't provide specific side effects of INZ-701, generally speaking, potential side effects could include reactions at the injection site, changes in blood pressure or heart rate during dialysis sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have end-stage kidney disease and am on dialysis.

Select...

I am between 18 and 70 years old.

Select...

I agree to use condoms and not donate sperm during and 30 days after my treatment.

Select...

I am following a thrice-weekly HD treatment with a working AV fistula, graft, or central catheter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 days (treatment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 days (treatment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 days (treatment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine if INZ-701 increases PPi levels

Secondary outcome measures

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

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

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

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: INZ-701Experimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Inozyme PharmaLead Sponsor

7 Previous Clinical Trials

1,128 Total Patients Enrolled

Kurt Gunter, MDStudy DirectorInozyme Pharma

5 Previous Clinical Trials

1,086 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria for participation in this experimental endeavor?

"Candidates aged between 18 and 69 years old with a diagnosis of calciphylaxis are eligible for inclusion in this study, which aims to enroll approximately 10 participants."

Answered by AI

Is it possible for patients to enroll in this ongoing clinical trial?

"Per information from clinicaltrials.gov, this research trial is presently enrolling volunteers. The study was initially shared on February 12th, 2024, and the latest revision occurred on February 21st of the same year."

Answered by AI

What is the current number of individuals being recruited for participation in this research endeavor?

"Indeed, information from clinicaltrials.gov confirms that this study is currently enrolling participants. It was first listed on February 12th, 2024, and the most recent update occurred on February 21st, 2024. The research aims to recruit a total of 10 individuals distributed across two distinct sites."

Answered by AI

Are individuals older than 65 years of age eligible to participate in this clinical trial?

"Applicants eligible for this research study must be between 18 and 69 years old. There are a total of 45 studies catering to individuals under 18 years old, whereas there are 546 studies targeting patients over the age of 65."

Answered by AI

Has INZ-701 received approval from the FDA for clinical use?

"In this Phase 1 investigation, INZ-701 has been assigned a safety rating of 1 by our team at Power due to the limited available data on its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06283589.

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