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IXP for Kidney Failure

Phase 1
Recruiting
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 day 1 through completion of study participation (up to a maximum of 17 days)
Awards & highlights

Summary

This trial will explore if a single dose of Inaxaplin works differently in people with severe kidney problems and people with normal kidneys.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~day 1 through completion of study participation (up to a maximum of 17 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through completion of study participation (up to a maximum of 17 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
Maximum Observed Plasma Concentration (Cmax) of IXP
Secondary outcome measures
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)

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.

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
247 Previous Clinical Trials
32,587 Total Patients Enrolled

Media Library

Inaxaplin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05865171 — Phase 1
Kidney Failure Research Study Groups: Cohort 1: Severe Renal Impairment, Cohort 1: Healthy Participants
Kidney Failure Clinical Trial 2023: Inaxaplin Highlights & Side Effects. Trial Name: NCT05865171 — Phase 1
Inaxaplin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05865171 — Phase 1
~8 spots leftby Jul 2025