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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
Must not have
Any condition affecting drug absorption, such as major surgery involving the stomach or small intestine (prior cholecystectomy is acceptable)
Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery on my stomach or small intestine.
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I do not have active hepatitis A, B, C, or HIV.
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I haven't had serious heart or lung problems in the last 6 months.
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My liver enzyme ALT levels are more than four times the upper limit.
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I haven't had cancer treatments except for non-melanoma skin cancer in the last 2 years.
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I am currently pregnant or breastfeeding.
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I have severe kidney problems or am on dialysis/have had a kidney transplant.
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I haven't used any blood cell growth boosters in the last 28 days.
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I am on regular blood transfusions or had one within the last 30 days.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in albuminuria in voxelotor-treated SCA patients compared to the observation patients by a one-sided test
Secondary study objectives
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
4%
Acute chest syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Voxelotor: SCD Related
Voxelotor: Non-SCD Related

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: 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

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,142 Total Patients Enrolled
Global Blood TherapeuticsIndustry Sponsor
35 Previous Clinical Trials
4,347 Total Patients Enrolled

Media Library

Voxelotor (Hemoglobin Modifiers) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335721 — Phase 1 & 2
~2 spots leftby Jul 2025
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