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Looking for participantsPhase1

Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease

Sponsor: AstraZeneca

NCT ID: NCT07228364

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD1613 - Part A (drug), Placebo - Part A (drug), AZD1613 - Part B (drug), Placebo - Part B (drug)
How long the study runs
Study runs about 18 months (dates as stated)
About the drug or intervention
AZD1613 - Part A — drug: Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. · Placebo - Part A — drug: Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT. · AZD1613 - Part B — drug: Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. · Placebo - Part B — drug: Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
40
Started
2025-11-10
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for autosomal dominant polycystic kidney disease
  • • Phase1 - 40 participants
  • • A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD)

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with autosomal dominant polycystic kidney disease

Where?

  • • London - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

This Phase I, randomised, single-blind, placebo-controlled study will assess the safety and tolerability of AZD1613 and characterise the pharmacokinetics (PK) of AZD1613 in participants with autosomal dominant polycystic kidney disease (ADPKD), following subcutaneous (SC) or intravenous (IV) administration. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD1613. Furthermore, the safety and PK profile will be evaluated in Chinese participants with ADPKD to assess any potential race effect in this population.

Autosomal Dominant Polycystic Kidney Disease

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results...
  • ✓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

Who cannot take part

  • ✗As judged by the investigator, any evidence of heart, vascular, and other kidney conditions which in the...
  • ✗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...
See the full 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.

Where Is This Study? (1 UK site)

Research Site

London NW3 2QG, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09