Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
← catalyst calendarNCT07228364 · readout in 276 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
40estimated
Sites
15
Countries
China, United Kingdom, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-11-10 | actual | When the study began enrolling |
| Primary completion | 2027-05-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-05-22 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Autosomal Dominant Polycystic Kidney Disease
Interventions
- Drug: AZD1613 - Part A
- Drug: Placebo - Part A
- Drug: AZD1613 - Part B
- Drug: Placebo - Part B
Primary outcomes
what the primary-completion date above is the date OFIncidence of Treatment-Emergent Adverse Events (TEAEs)
measured From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days)
Change From Baseline in Safety 12-Lead ECG QTcF
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Safety 12-Lead ECG PR Interval
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Safety 12-Lead ECG QRS Duration
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Heart Rate (12-Lead Safety ECG)
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in ALT
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in AST
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Total Bilirubin
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Serum Creatinine
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR; CKD-EPI 2021)
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in INR
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Prothrombin Time (PT)
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR)
measured Baseline (Day -1) and scheduled visits through Day 189 ±3 days; UACR as triplicate first-morning voids per visit
Change From Baseline in Systolic Blood Pressure
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Diastolic Blood Pressure
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Heart Rate (Vital Signs)
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Body Temperature
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Respiratory Rate
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Oxygen Saturation (SpO2)
measured Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
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