What side effects are associated with this type of intervention?

Common treatments for kidney failure include medications like ACE inhibitors, ARBs, and immunosuppressive therapies. Known side effects of these treatments can include hyperkalemia, hypotension, and increased risk of infections. Specific to immunosuppressive therapies, side effects may also include gastrointestinal distress, elevated liver enzymes, and increased susceptibility to malignancies. For treatments similar to Inaxaplin, which is under study for its pharmacokinetics and safety in renal impairment, side effects could potentially include those related to drug metabolism and excretion issues in patients with compromised kidney function.

What prior FDA approvals exist?

Several FDA-approved treatments have been evaluated for their efficacy and safety in patients with renal impairment. Cyclophosphamide, often combined with methylprednisolone, has shown improved long-term renal outcomes in lupus nephritis without adding significant toxicity. Lenalidomide and dexamethasone have been effective in multiple myeloma patients with varying degrees of renal impairment, reducing the risk of disease progression or death. Additionally, pegylated liposomal doxorubicin combined with bortezomib has demonstrated efficacy in relapsed or refractory multiple myeloma patients with renal insufficiency. These treatments highlight the importance of evaluating pharmacokinetics and safety in renal impairment, similar to the ongoing study of Inaxaplin (IXP).

What other types of research exist?

Promising alternatives to Inaxaplin (IXP) for kidney failure patients include Eculizumab and Isatuximab. Eculizumab has been shown to be effective in controlling atypical hemolytic uremic syndrome (aHUS) in patients with renal impairment, although its discontinuation carries a risk of relapse. Isatuximab, combined with pomalidomide and dexamethasone, has demonstrated safety and efficacy in patients with multiple myeloma and renal impairment, including those on hemodialysis.

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IXP for Kidney Failure

Phase 1

Waitlist Available

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called Inaxaplin to see how it behaves in the body and if it is safe. It includes people with severe kidney problems and healthy individuals to compare results. The study will measure how the drug is absorbed, processed, and removed from the body.

Who is the study for?

This trial is for adults with stable kidney function or severe renal impairment who have maintained this condition for at least a month. They should have a BMI between 18.5 to 40 kg/m^2. People with uncontrolled high blood pressure or conditions that could affect drug absorption cannot participate.

What is being tested?

The study is testing the effects and safety of a single dose of Inaxaplin (IXP) in individuals with severe kidney problems compared to healthy participants with normal kidney function.

What are the potential side effects?

While specific side effects are not listed, they typically include reactions at the injection site, potential changes in blood tests related to kidney function, and general symptoms like fatigue or nausea.

Eligibility Criteria

Exclusion Criteria

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

Select...

My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 1: Severe Renal ImpairmentExperimental Treatment1 Intervention

Participants will receive a single dose of IXP on Day 1.

Group II: Cohort 1: Healthy ParticipantsExperimental Treatment1 Intervention

Participants will receive a single dose of IXP on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IXP

2023

Completed Phase 1

~20

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure include glucocorticoids, ACE inhibitors, ARBs, and emerging drugs like Inaxaplin (IXP). Glucocorticoids reduce inflammation and immune response, which can slow the progression of kidney damage. ACE inhibitors and ARBs lower blood pressure and reduce proteinuria, protecting kidney function by decreasing the workload on the kidneys. Inaxaplin (IXP) is being studied for its pharmacokinetics and safety in patients with renal impairment, potentially offering a new therapeutic option. These treatments are crucial as they aim to preserve kidney function, delay the progression to end-stage kidney disease, and improve patient outcomes.

Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and cost-effectiveness analysis.Year in review 2005: critical care--nephrology.