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INZ-701 for Kidney Disease

Phase 1

Waitlist Available

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

Must not have

Myocardial infarction, stroke, or congestive heart failure requiring hospitalization within the last 6 months

Weight >125 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 days (treatment period)

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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I am between 18 and 70 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a heart attack, stroke, or severe heart failure in the last 6 months.

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I weigh more than 125 kg.

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I am on a form of dialysis that is not hemodialysis.

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I haven't had cancer in the past year, except for skin cancer or early cervical cancer.

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My condition is advanced liver disease with cirrhosis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine if INZ-701 increases PPi levels

Secondary study objectives

Assess ENPP1 Activity

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

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met