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

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

CT.gov Identifier
NCT07228364
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
AstraZeneca
Collaborator
N/A
Study Contact Information
+44 20 3749 5000
Recruiting
Contact Us

Study Details

Diseases
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Drug
AZD-1613
Genes
PKD1
GANAB
Study Dates
Nov 2025 - Jan 2027
Sex
Female & Male
Age
18 - 65 Years
Inclusion and 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.

Protocol Summary

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

Study Locations

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