AZD4248 for Diabetic Kidney Disease

Recruiting at 4 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: ACEi, ARB

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Hepatitis, HIV, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

164 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD4248 for diabetic kidney disease (DKD). Researchers aim to assess its safety and effectiveness when administered in different forms, such as a pill or through an IV. They are also evaluating whether participants can measure a kidney health marker at home. Individuals with diabetic kidney disease who have maintained stable medication may qualify for the study. Participants must use a home device to monitor their kidney health. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the unique opportunity to be among the first to receive it.

Do I have to stop taking my current medications to join the trial?

Participants need to be on a stable dose of their current medications, including angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB), for at least 6 weeks before the trial and throughout the screening period. If you are taking drugs that affect serum creatinine, you should be on a stable dose before joining the study.

Is there any evidence suggesting that AZD4248 is likely to be safe for humans?

Research shows that AZD4248 has been tested in both healthy individuals and those with chronic kidney problems. Earlier studies have assessed its safety and tolerability, finding no major safety issues. Overall, participants have tolerated AZD4248 well. Although testing is still in its early stages, no serious side effects have been reported.

This study is in an early phase, focusing primarily on safety. While specific results from other studies remain unclear, testing AZD4248 in people suggests initial confidence in its safety. Joining a trial involves some risk, but safety remains a top priority in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AZD4248 is unique because it targets diabetic kidney disease differently than most existing treatments. Traditional therapies often focus on controlling blood pressure or blood sugar levels, but AZD4248 is designed to address the underlying mechanisms of kidney damage directly. This drug is administered in both oral and intravenous forms, offering flexibility in treatment. Researchers are excited about its potential to provide a more targeted approach, which could lead to better outcomes for patients suffering from this condition.

What evidence suggests that AZD4248 might be an effective treatment for diabetic kidney disease?

Research shows that AZD4248 is being tested in this trial to determine its effectiveness in managing diabetic kidney disease (DKD). Participants in various treatment arms will receive different dosing regimens of AZD4248 or a placebo. The drug aims to improve kidney function by targeting the causes of kidney damage in diabetes. Early results suggest AZD4248 might slow the progression of kidney disease. Although limited information exists on its efficacy in people, its mechanism offers hope for benefits in DKD. As research progresses, more will be learned about AZD4248's effectiveness for those with diabetic kidney disease. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with chronic kidney disease (CKD) or type 2 diabetes, specifically focusing on diabetic kidney disease. Participants should be willing to take oral solutions or IV infusions of the drug AZD4248 or a placebo, and measure their serum creatinine at home.

Inclusion Criteria

For Parts A and B: BMI between 18 and 30 kg/m2, inclusive

For Chinese participants (Part A2): participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese

For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese

Exclusion Criteria

I don't have any health conditions that could make this study risky for me.

I am not on a stable dose of medication that affects my kidney function.

I haven't had severe illnesses, surgeries, or allergies, nor taken AZD4248 before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of AZD4248 as oral solution or IV infusion

1 week

Multiple visits (in-person)

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of AZD4248

17 days

Multiple visits (in-person)

Non-interventional Cohort

Participants with DKD perform home-based creatinine self-measurement

169 days

Home-based assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD4248

Trial Overview The study tests AZD4248's safety and how the body responds to it when given in different doses orally or through an IV. It also looks at how well participants can measure their own kidney function using serum creatinine levels at home.

How Is the Trial Designed?

Group I: Part C Multiple Dosing DKD Experimental Treatment 2 Interventions

Participants will receive multiple oral doses of AZD4248 or placebo.

Group II: Part B2 MAD Japanese Experimental Treatment 2 Interventions

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

Group III: Part B1 MAD Experimental Treatment 2 Interventions

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

Group IV: Part A3 SAD IV Cohort Experimental Treatment 2 Interventions

Participants will receive single IV infusion of AZD4248 or placebo.

Group V: Part A2 SAD Chinese Cohort Experimental Treatment 2 Interventions

Participants will receive single oral dose of AZD4248 or placebo.

Group VI: Part A1 SAD Experimental Treatment 2 Interventions

Participants will receive single ascending oral dose of AZD4248 or placebo.

Group VII: Part D Observational Cohort Active Control 1 Intervention

Participants will participate in home-based creatinine self-measurement.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. withpower.com withpower.com/trial/phase-1-renal-insufficiency-chronic-5-2025-7089c

AZD4248 for Diabetic Kidney Disease This Phase 1 medical study run by AstraZeneca is evaluating whether AZD4248 will have tolerable side effects & efficacy for patients with Type 2 Diabetes, ...

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D8380C00001

A Study to Investigate Safety, Tolerability ... A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants with Chronic Kidney ...

3. tipranks.com tipranks.com/news/company-announcements/astrazenecas-azd4248-study-a-promising-step-in-diabetic-kidney-disease-treatment

AstraZeneca's AZD4248 Study: A Promising Step in ... The primary goal is to determine the drug's safety and effectiveness in managing diabetic kidney disease. This randomized, single-blind ...

4. tipranks.com tipranks.com/news/company-announcements/astrazenecas-promising-azd4248-study-a-potential-game-changer-in-chronic-kidney-disease-and-diabetes-treatment

AstraZeneca's Promising AZD4248 Study: A Potential ... ' The study aims to evaluate the safety and effectiveness of AZD4248, a potential treatment for chronic kidney disease and type 2 diabetes, and ...

5. astrazeneca.com astrazeneca.com/content/dam/az/PDF/2025/h1q2/H1-and-Q2-2025-results-clinical-trials-appendix.pdf

Clinical Trials Appendix • Data anticipated: H2 2025. Phase I. NCT06693765. Participants with renal impairment, end-stage kidney disease and healthy volunteers. 41.

6. meddatax.com meddatax.com/clinical-trials/NCT07024823

A Study to Investigate Safety, Tolerability, Pharmacokinetics ... A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With ...

7. policylab.us policylab.us/clinical-trials/l/conditions/chronic-kidney-disease

Chronic Kidney Disease Clinical Trials - Policy Lab The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with ...