A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort

{ "A Study of AZD4248 for Chronic Kidney Disease and Type 2 Diabetes", "This study is looking at a new medication called AZD4248, given either by mouth or through an IV. Researchers want to see how safe it is, how well your body handles it, and how it moves through your system. The study includes healthy volunteers and people with chronic kidney disease (CKD) and type 2 diabetes. It also explores if people with diabetic kidney disease (DKD) can accurately measure their own creatinine levels at home. To join, you should be between 18 and 75 years old. For parts of the study, healthy participants need to have a Body Mass Index (BMI) between 18 and 30. The main goals are to track any side effects and to see how consistent home creatinine measurements are. The study is currently recruiting up to 124 participants.", "design": "This is a randomized, single-blind, placebo-controlled study involving healthy participants and those with chronic kidney disease and type 2 diabetes. It is a Phase 1 study, the first time AZD4248 is being tested in humans.", "commitments": "Participants will receive AZD4248 or a placebo, either orally or through an IV. The study involves different parts with varying durations, from up to 12 days to up to 169 days, depending on the part you join.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for up to 12 days for some parts of the study, up to 19 days for other parts, and up to 169 days for the part assessing home creatinine measurements.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort

Recruiting

PHASE1Ages 18–75InterventionalTreatment

AstraZeneca

~124 participants

Updated 2026-08-12 on ClinicalTrials.gov

What's tested:AZD4248Placebo

At a glance

Recruiting sites

4 of 5 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Parts A, B, and C: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Measured over From Day 1 to Follow Up visit (Part A: up to 12 days; Part B and C: up to 19 days)

+1 more outcome measured

Conditions

Chronic Kidney Disease

Where it's being run

5 sites across 5 states

California1

Illinois1

Michigan1

Minnesota1

Texas1

Who to contact

AstraZeneca Clinical Study Information Center

[email protected]

1-877-240-9479

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg/m2), inclusive.

For Chinese participants (Part A2): participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.

For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.

Have a BMI between 20 and 40 kg/m2, inclusive.

Have a diagnosis of diabetic kidney disease (DKD).

Hemoglobin A1C (HbA1c) of ≤ 10.5%.

Participants are required to be on a stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.

Have a BMI between 20 and 35 kg/m2, inclusive.

Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values.

HbA1c of ≤ 10.5%.

Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.

Participants must be able and motivated to use the home creatinine device and smartphone independently by successfully performing the test without assistance from site staff.

Participants must be able to read and understand English sufficient to participate in site visits and home testing.

Exclusion

History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.

Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV).

History or presence of gastrointestinal, hepatic, or renal disease.

Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.

History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.

Participants who have previously received AZD4248.

History or presence of gastrointestinal, hepatic, or renal disease.

Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.

History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.

Use of drugs that are strong or moderate CYP3A4 inhibitors/inducers or P-gp inhibitors from within 3 weeks before Screening until the end of the last sample collection.

Participants who have previously received AZD4248.

Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.

Expected change of dosing regimen during the study.

History of clinically significant heart or vascular disease.

New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening.

Ventricular arrhythmias requiring treatment.

Amputation due to peripheral artery disease.

Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months.

Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.

Expected change of dosing regimen during the study.

What this trial measures

Parts A, B, and C: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day 1 to Follow Up visit (Part A: up to 12 days; Part B and C: up to 19 days)
To assess the safety and tolerability of AZD4248 following single oral ascending doses or single IV administration to healthy participants and multiple oral ascending doses to healthy participants and participants with CKD and T2D (DKD).
Part D: Intra- and inter-participant variability of estimated glomerular filtration rate (eGFR) derived from home self-testing device measurementsDay 1 to Day 169
To assess intra- and inter-participant variability of twice weekly home-based serum creatinine measurements.

Trialytics