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A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease
EU CTIS ID: 2024-517525-10-00
What this study is testing
To evaluate the safety and tolerability of MZE829 in adults with proteinuric APOL1 kidney disease
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 to 68 years of age (inclusive) at the time of signing the informed consent
- Being of recent African descent (e.g., African American, Afro-Caribbean, Afro-Latinx, or African ancestry), regardless of current racial or self-identification
- Body mass index (BMI) of 18 to ≤45 kg/m2 and total body weight of ≥40 kg
- Confirmed APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- Diagnosis of chronic kidney disease with persistent high urine albuminuria
- Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 at Screening based on the Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI Creatinine-Cystatin C) equation
You likely can't join if
- Any condition that in the opinion of the Investigator would interfere with the evaluation of the investigational product or lead to increased risk of harm
- Use of any potent immunosuppressants within 5 PK half-lives or 12 weeks prior to Screening, whichever is longer
- Use of oral corticosteroids equivalent to prednisone >10 mg/day for more than 1 day or any use of systemic corticosteroids equivalent to prednisone >10 mg within approximately 8 weeks prior to Screening
- Clinically significant abnormal laboratory test results with the exception of abnormalities considered by the Investigator to be the result of underlying disease.
- Clinically significant abnormal Screening ECG, including but not limited to QTcF >450 ms or history of QT interval prolongation
See the full eligibility criteria
- 18 to 68 years of age (inclusive) at the time of signing the informed consent
- Being of recent African descent (e.g., African American, Afro-Caribbean, Afro-Latinx, or African ancestry), regardless of current racial or self-identification
- Body mass index (BMI) of 18 to ≤45 kg/m2 and total body weight of ≥40 kg
- Confirmed APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- Diagnosis of chronic kidney disease with persistent high urine albuminuria
- Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 at Screening based on the Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI Creatinine-Cystatin C) equation
- History of proteinuria
- Any condition that in the opinion of the Investigator would interfere with the evaluation of the investigational product or lead to increased risk of harm
- Use of any potent immunosuppressants within 5 PK half-lives or 12 weeks prior to Screening, whichever is longer
- Use of oral corticosteroids equivalent to prednisone >10 mg/day for more than 1 day or any use of systemic corticosteroids equivalent to prednisone >10 mg within approximately 8 weeks prior to Screening
- Clinically significant abnormal laboratory test results with the exception of abnormalities considered by the Investigator to be the result of underlying disease.
- Clinically significant abnormal Screening ECG, including but not limited to QTcF >450 ms or history of QT interval prolongation
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.