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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through completion of study participation (up to a maximum of 17 days)

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through completion of study participation (up to a maximum of 17 days)

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.

Do I qualify?Apply below to find out

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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

243 Previous Clinical Trials

32,371 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

Frequently Asked Questions

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

Is it feasible for me to join this research study?

"The qualifications for this clinical trial are a diagnosis of kidney failure and an age between 18 and 80. At present, roughly 16 participants are being enrolled."

Answered by AI

Are there currently opportunities to enroll in this experiment?

"This clinical trial remains open, as indicated on the clinicaltrials.gov website. It was initiated on June 12th 2023 and underwent its last update two days later on June 21st 2023."

Answered by AI

Does this research study have age restrictions, and if so, does it preclude individuals above a certain chronological threshold?

"This clinical trial mandates that all participants are aged 18 or older, with the upper limit set at 80 years old."

Answered by AI

How many people are taking part in this experiment?

"Affirmative. According to the resources located on clinicaltrials.gov, this experiment is currently enrolling volunteers; it was initially posted on June 12th 2023 and last updated on June 21st of the same year. A total of 16 participants are required between two trial sites."

Answered by AI

What potential risks are posed to participants in Cohort 1: Healthy Participants?

"Minimal evidence exists to support the safety of Cohort 1: Healthy Participants, so it is given an assessment of 1. This evaluation is based on its Phase 1 status which implies a scarce amount of data regarding effectiveness and protection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment

2023. "A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05865171.