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AZD1613 safety and how the body handles it in adults with ADPKD

A Phase I Randomised, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1613 Following Multiple Ascending Dose Administration in Participants With Autosomal Dominant Polycystic Kidney Disease

Phase 1 Interventional AstraZeneca · NCT07228364

We will test whether AZD1613 given under the skin or into a vein is safe and how the body processes it in adults with ADPKD who have eGFR between 45 and 90 mL/min/1.73m2.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations15 sites (Birmingham, Alabama and 14 other locations)
Trial IDNCT07228364 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, single-blind, placebo-controlled trial administers AZD1613 subcutaneously or intravenously to adults with ADPKD to measure safety, tolerability, and pharmacokinetics. Eligible participants are centrally classified as Mayo Class IB–IE with eGFR 45–90 mL/min/1.73m2, weigh at least 45 kg, and have BMI between 18 and 35 kg/m2, and females must be non-childbearing. The design includes placebo arms to benchmark safety and a cohort of Chinese participants to explore potential race effects on drug handling. Safety monitoring emphasizes cardiac, renal, and laboratory assessments and recording of adverse events after dosing.

Who should consider this trial

Good fit: Adults with ADPKD Mayo Class IB–IE, eGFR 45–90 mL/min/1.73m2, body weight ≥45 kg, BMI 18–35 kg/m2, and females who are non-childbearing are the intended candidates.

Not a fit: Patients with more advanced kidney failure (eGFR <45), active hepatitis or HIV, congenital long QT or significant ventricular arrhythmias, pregnant or childbearing females, or other investigator‑judged high‑risk conditions are unlikely to be eligible or to benefit from this Phase 1 safety trial.

Why it matters

Potential benefit: If later trials confirm benefit, AZD1613 could become a new treatment option that helps slow ADPKD progression or manage symptoms with an acceptable safety profile.

How similar studies have performed: Early-phase safety and PK studies are standard and have supported later success for other ADPKD drugs (for example, tolvaptan), but AZD1613 itself is novel and unproven in this population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes
* eGFR = 45 to 90 mL/min /1.73m2
* Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive).
* Females are to be of non-childbearing potential

Exclusion Criteria:

* As judged by the investigator, any evidence of cardiac, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the participant to participate in the study.
* Positive hepatitis C antibody, hepatitis B virus surface antigen, or human immunodeficiency virus test, at screening.
* History of QT prolongation associated with other medications that required discontinuation of that medication.
* Congenital long QT syndrome.
* History of ventricular arrhythmia requiring treatment. Patients with atrial fibrillation/flutter and controlled ventricular rate HR \< 100 bpm can be eligible as judged by the investigator.
* Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator.
* Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator.
* Systolic BP \> 160 mmHg or diastolic BP \> 100mmHg or HR \< 50 bpm or \> 100 bpm at screening. Patients taking anti-hypertensive medication should be on a stable treatment regimen of antihypertensive therapy for at least 30 days prior to the screening visit.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
* Kidney cyst interventions such as cyst aspiration or cyst fenestration within 12 weeks prior to screening and during the screening period, or such interventions planned or anticipated within the follow-up period.

Where this trial is running

Birmingham, Alabama and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Autosomal Dominant Polycystic Kidney Disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.