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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Jacksonville, Florida, United States Recruiting
• Research Site
  Orlando, Florida, United States Recruiting
• Research Site
  Lenexa, Kansas, United States Recruiting
• Research Site
  Baltimore, Maryland, United States Recruiting
• Research Site
  Rochester, Minnesota, United States Recruiting
• Research Site
  Chengdu, China Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Managing Depressive Symptoms in ADPKD: testing Digital Neurotherapy and Capacity Coaching

  This study tests whether Digital Neurotherapy or Capacity Coaching can help people with ADPKD who have depression and self-reported pain, compared to education alone.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07745920

• Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease

  This trial will test whether intravenous ABBV-CLS-628 given every 4 weeks is safe and helps adults with ADPKD.

  Recruiting at 72 sites Phase 2 Calico Life Sciences LLC · Birmingham, Alabama and 90 other locations · NCT06902558

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

• Using Metformin to Slow Kidney Decline in Polycystic Kidney Disease

  This study is testing if metformin can help slow down kidney problems in adults with early-stage Polycystic Kidney Disease.

  Recruiting at 24 sites Phase 3 The University of Queensland · Gosford, New South Wales and 48 other locations · NCT04939935

• Evaluating biomarkers in early autosomal dominant polycystic kidney disease

  This study is trying to see if certain biomarkers can help understand how severe early autosomal dominant polycystic kidney disease is for young patients aged 15 to 40.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04630613

• Understanding oxidative stress in patients with Autosomal Dominant Polycystic Kidney Disease

  This study is testing how oxidative stress affects young adults with Autosomal Dominant Polycystic Kidney Disease to find better ways to treat the condition.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04344769

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.