Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Recruiting
Phase 2Interventional Study
Diabetic Kidney Disease (DKD)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
195 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with diabetic kidney disease to test some new medications. Participants will help researchers understand how safe and effective these medications are.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with type 2 diabetes
I have an HbA1c between 6.5% and 10%
My eGFR is between 30 and 90 mL/min/1.73 m²
I have an urine albumin to creatinine ratio between 500 and 5000 mg/g
You may not be able to join if
I have a history of non-diabetic kidney disease
I have needed treatment with strong immune-suppressing drugs
I am medically unstable according to my doctor
I was hospitalized for more than 24 hours in the last 30 days
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on participants who have diabetic kidney disease.
The aim of the study is to see how safe and effective the study drugs are.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood …
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on participants who have diabetic kidney disease.
The aim of the study is to see how safe and effective the study drugs are.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management
2. Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening
3. eGFR 30 to 90 mL/min/1.73 m\^2 using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated…
Key Inclusion Criteria:
1. Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management
2. Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening
3. eGFR 30 to 90 mL/min/1.73 m\^2 using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated Glomerular Filtration Rate using Creatinine and Cystatin C (CKD-EPI eGFRcr-cys) equation at screening
4. Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening
Key Exclusion Criteria:
1. Known medical history or clinical evidence indicative of non-diabetic renal disease
2. Renal disease that required treatment with systemic immunosuppressive therapy (prior or current), or a history of end-stage kidney disease requiring treatment with chronic dialysis or kidney transplantation
3. Medically unstable as assessed by the investigator or hospitalization (ie, \>24 hours) within 30 days of the screening visit
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
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