Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
Key facts
- Where
- Baltimore, Birmingham, Jacksonville, Lenexa, Loma Linda, Orlando, Rochester, and San Antonio, United StatesSee the 8 sites
- Phase
- Phase 1
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 United States
- BaltimoreBaltimore, United StatesTaking people
- BirminghamBirmingham, United StatesNot yet recruiting
- JacksonvilleJacksonville, United StatesTaking people
- LenexaLenexa, United StatesTaking people
- Loma LindaLoma Linda, United StatesNot yet recruiting
- OrlandoOrlando, United StatesTaking people
- RochesterRochester, United StatesTaking people
- San AntonioSan Antonio, United StatesNot yet recruiting
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.