Safety, Tolerability And Pharmacokinetics Of AZD1613 In Adults With Autosomal Dominant Polycystic Kidney Disease

Overview

About this study

A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/18/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Neera Dahl

Contact us for the latest status

Contact information:

Ryan Helland

(507) 422-3998

helland.ryan@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20597989

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