Actively Recruiting
Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
Led by AstraZeneca · Updated on 2026-05-11
40
Participants Needed
15
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
CONDITIONS
Official Title
Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ADPKD Mayo Class IB to IE confirmed by clinical assessment
- Estimated glomerular filtration rate (eGFR) between 45 and 90 mL/min/1.73m2
- Body weight at least 45 kg and body mass index between 18 and 35 kg/m2
- Females must be of non-childbearing potential
You will not qualify if you...
- Any cardiac, vascular, or renal conditions that make participation unsafe as judged by the investigator
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or HIV at screening
- History of QT prolongation requiring medication discontinuation
- Congenital long QT syndrome
- History of ventricular arrhythmia requiring treatment
- Significant haematological abnormalities or hemoglobin below normal range
- Clinically important abnormalities in chemistry, haematology, coagulation, or urinalysis as judged by the investigator
- Blood pressure over 160/100 mmHg or heart rate below 50 or above 100 bpm at screening
- Unstable or abnormal ECG findings that interfere with QTc interval assessment
- Kidney cyst interventions within 12 weeks before screening or planned during follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Research Site
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Research Site
Loma Linda, California, United States, 92354
Not Yet Recruiting
3
Research Site
Jacksonville, Florida, United States, 32216
Actively Recruiting
4
Research Site
Orlando, Florida, United States, 32808
Actively Recruiting
5
Research Site
Lenexa, Kansas, United States, 66219
Actively Recruiting
6
Research Site
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
7
Research Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Research Site
San Antonio, Texas, United States, 78212
Not Yet Recruiting
9
Research Site
Chengdu, China, 610072
Not Yet Recruiting
10
Research Site
Hangzhou, China, 310003
Not Yet Recruiting
11
Research Site
Nanjing, China, 210009
Not Yet Recruiting
12
Research Site
Shanghai, China, 200025
Not Yet Recruiting
13
Research Site
Wuhan, China, 430022
Not Yet Recruiting
14
Research Site
Xiamen, China, 361101
Not Yet Recruiting
15
Research Site
London, United Kingdom, NW3 2QG
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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