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Hemoglobin Modifiers

Voxelotor for Sickle Cell Anemia with Chronic Kidney Disease

Phase 1 & 2

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

Study Summary

This trial will study sickle cell anemia patients with early stages of kidney disease to see if they are at high risk for the disease progressing.

Who is the study for?

Adults over 18 with Sickle Cell Anemia (SCA) who are at high risk of worsening kidney disease, specifically those with early-stage sickle cell nephropathy and stable medication doses. Participants must not be pregnant or breastfeeding, have no severe infections or recent blood transfusions, and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing Voxelotor in patients with SCA at an early stage of chronic kidney disease but high risk for progression. It's a forward-looking study where all participants receive the same treatment without a comparison group.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed, Voxelotor may commonly cause headache, diarrhea, abdominal pain, nausea, fatigue, rash and fever. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in albuminuria in voxelotor-treated SCA patients compared to the observation patients by a one-sided test

Secondary outcome measures

Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in In kidney function measure

Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in Kidney function measure

Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in albuminuria

+5 more

Side effects data

From 2022 Phase 4 trial • 25 Patients • NCT04400487

32%

Sickle cell anaemia with crisis

Acute chest syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Voxelotor: SCD Related

Voxelotor: Non-SCD Related

Trial Design

2Treatment groups

Experimental Treatment

Group I: VoxelotExperimental Treatment1 Intervention

Voxelotor 1500mg once a day

Group II: Standard of Care (SOC)Experimental Treatment1 Intervention

Observational while receiving SOC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Voxelotor

2023

Completed Phase 4

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,297 Total Patients Enrolled

Global Blood TherapeuticsIndustry Sponsor

35 Previous Clinical Trials

4,865 Total Patients Enrolled

Media Library

Voxelotor (Hemoglobin Modifiers) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335721 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment still active for this research endeavor?

"Affirmative. Per clinicaltrials.gov, this medical trial is actively looking for participants and was initially posted on March 16th 2021. As of June 16th 2022, 12 patients are being sought from a single site to participate in the study."

Answered by AI

What is the maximum number of participants recruited for this research endeavor?

"Indeed, according to clinicaltrials.gov, this investigation is currently accepting participants. The initial posting of the study was on March 16th 2021 and it has been revised as recently as June 16th 2022. This research requires 12 volunteers at a single site."

Answered by AI

What prior research has utilized Voxelotor in its investigations?

"Currently, there are 7 ongoing clinical trials for Voxelotor with 3 in the later stages of their study. While Atlanta is a primary site for these studies, there are 139 other locations running similar experiments."

Answered by AI

Is this research unprecedented in its scope and goals?

"Global Blood Therapeutics sponsored Voxelotor's first clinical trial in 2016, which included 155 participants. After demonstrating efficacy and safety during this study, the drug was approved for Phase 2 trials. Currently there are over 7 ongoing studies taking place across 14 nations to further assess its use - each of these investigations being conducted at 39 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease

Santosh L Saraf 2021. "A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04335721.

All > Chronic Kidney Disease > Sickle Cell Anemia