Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
Key facts
- Where
- Chengdu, Hangzhou, Nanjing, Shanghai, Wuhan, and Xiamen, ChinaSee the 6 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with autosomal dominant polycystic kidney disease (ADPKD) and mildly to moderately reduced kidney function. It tests the safety and handling in the body of AZD1613.
- Age
- 18 to 65 years
- Sex
- All sexes. Women must be unable to have children.
- Disease stage
- ADPKD, Mayo Class IB to IE, based on the clinical diagnosis checked centrally. Kidney function (eGFR) of 45 to 90 mL/min/1.73m2.
- Earlier treatment
- People taking blood pressure medicine must have been on a stable dose for at least 30 days before screening. No kidney cyst procedure within 12 weeks before screening.
- Biomarker or test result
- Genetic test results are not used to decide who can join.
Main reasons for not taking part
- Heart, blood vessel or other kidney problems that the investigator judges make taking part undesirable
- Positive test for hepatitis B, hepatitis C or HIV at screening
- History of long QT syndrome or of QT prolongation caused by other medicines
- History of ventricular arrhythmia that needed treatment
- Blood pressure above 160/100 mmHg or heart rate below 50 or above 100 bpm at screening
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07228364, who can take part
Where in China
- ChengduChengdu, ChinaTaking people
- HangzhouHangzhou, ChinaTaking people
- NanjingNanjing, ChinaTaking people
- ShanghaiShanghai, ChinaNot yet recruiting
- WuhanWuhan, ChinaNot yet recruiting
- XiamenXiamen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07228364
- Record updated
- 13 October 2026
- Original description
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).Read full original descriptionShow less
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).
Inclusion: 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: 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; 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; 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 ventricular arrhythmia requiring treatment. Patients with atrial fibrillation/flutter and controlled ventricular rate HR < 100 bpm can be eligible as judged by the investigator; History of QT prolongation associated with other medications that required discontinuation of that medication; Congenital long QT syndrome; 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 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; 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.