Autosomal Dominant Polycystic Kidney DiseasePhase 1PIONEER-PKDNCT07228364
Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
A Phase 1 study testing AZD1613 - Part A and AZD1613 - Part B in people with Autosomal Dominant Polycystic Kidney Disease, run by AstraZeneca at 15 sites in 3 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- AZD1613 - Part A and AZD1613 - Part B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 10 Nov 2025to 22 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
15 sites in 3 countries
United States8 sites, 8 recruiting
- Recruiting
Research Site
Baltimore, Maryland, 21201
- Not yet recruiting
Research Site
Birmingham, Alabama, 35233
- Recruiting
Research Site
Jacksonville, Florida, 32216
- Recruiting
Research Site
Lenexa, Kansas, 66219
- Not yet recruiting
Research Site
Loma Linda, California, 92354
- Recruiting
Research Site
Orlando, Florida, 32808
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Not yet recruiting
Research Site
San Antonio, Texas, 78212
China6 sites, 6 recruiting
- Recruiting
Research Site
Chengdu, 610072
- Recruiting
Research Site
Hangzhou, 310003
- Recruiting
Research Site
Nanjing, 210009
- Not yet recruiting
Research Site
Shanghai, 200025
- Not yet recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Xiamen, 361101
United Kingdom1 site, 1 recruiting
- Recruiting
Research Site
London, NW3 2QG
About this study
Official title: 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).
Read the detailed description
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.
- Being tested
- AZD1613 - Part A, Placebo - Part A, AZD1613 - Part B, Placebo - Part B
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1613 - Part ADrug
Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Placebo - Part ADrug
Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
AZD1613 - Part BDrug
Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Placebo - Part BDrug
Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Cohort A1 | Experimental | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. Receives: Drug: AZD1613 - Part A; Drug: Placebo - Part A |
| Part A - Cohort A2 | Experimental | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. Receives: Drug: AZD1613 - Part A; Drug: Placebo - Part A |
| Part B - Chinese Cohort | Experimental | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. Receives: Drug: AZD1613 - Part A; Drug: AZD1613 - Part B; Drug: Placebo - Part B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants with at least one TEAE and SAE, including events leading to discontinuation or death; coded by system organ class and preferred term.
Unit: participants.
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
Change from baseline in QT interval corrected using Fridericia's formula (QTcF) measured on single 12-lead safety ECGs.
Unit: milliseconds (ms).
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
Change from baseline in PR interval measured on single 12-lead safety ECGs.
Unit: milliseconds (ms).
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
Change from baseline in QRS duration measured on single 12-lead safety ECGs.
Unit: milliseconds (ms).
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)
Change from baseline in heart rate measured on single 12-lead safety ECGs.
Unit: beats per minute (bpm).
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in ALT
Change from baseline in alanine aminotransferase.
Unit: U/L.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in AST
Change from baseline in aspartate aminotransferase.
Unit: U/L.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Total Bilirubin
Change from baseline in total bilirubin.
Unit: mg/dL.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Serum Creatinine
Change from baseline in serum creatinine.
Unit: mg/dL.
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)
Change from baseline in eGFR calculated using CKD-EPI 2021.
Unit: mL/min/1.73 m².
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in INR
Change from baseline in international normalized ratio- (INR).
Unit: unitless.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Prothrombin Time (PT)
Change from baseline in prothrombin time.
Unit: seconds (s).
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Change from baseline in aPTT.
Unit: seconds (s).
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)
Change from baseline in UACR (geometric mean of triplicates at each visit).
Unit: mg/g.
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
Change from baseline in supine systolic blood pressure.
Unit: mmHg.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Diastolic Blood Pressure
Change from baseline in supine diastolic blood pressure.
Unit: mmHg.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Heart Rate (Vital Signs)
Change from baseline in supine heart rate.
Unit: bpm.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Body Temperature
Change from baseline in oral body temperature.
Unit: °C.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate.
Unit: breaths per minute.
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Oxygen Saturation (SpO2)
Change from baseline in pulse oximetry oxygen saturation.
Unit: percent (%).
Measured: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Secondary outcomes (9)
Maximum Observed Serum Concentration (Cmax) of AZD1613
Maximum observed serum concentration following subcutaneous or intravenous administration.
Unit: µg/mL.
Measured: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Area Under the Concentration-Time Curve to Last Quantifiable Concentration (AUClast) of AZD1613
AUC from time zero to last quantifiable concentration.
Unit: h·µg/mL (or day·µg/mL; align with bioanalytical report).
Measured: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of AZD1613
AUC from time zero extrapolated to infinity.
Unit: h·µg/mL (or day·µg/mL).
Measured: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau) of AZD1613
AUC over the dosing interval at steady state.
Unit: h·µg/mL (or day·µg/mL).
Measured: Over the dosing interval (τ = 28 days) at steady state; sampling through Day 189
Time to Maximum Observed Serum Concentration (Tmax) of AZD1613
Time to reach Cmax after dosing.
Unit: hours (h).
Measured: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Terminal Elimination Half-Life (t½) of AZD1613
Half-life associated with terminal slope (λz) of the concentration-time curve.
Unit: hours (h) or days (d).
Measured: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Incidence of Anti-Drug Antibodies (ADA) to AZD1613
Number of participants with ADA-positive response based on validated tiered assay (screen and confirm).
Unit: participants.
Measured: Predose on dosing days and during follow-up through Day 189 ±3 days
ADA Titer to AZD1613
Titer among confirmed ADA-positive samples.
Unit: reciprocal dilution (titer).
Measured: Predose on dosing days and during follow-up through Day 189 ±3 days
Change From Baseline in PD Markers of PAPPA-1 Inhibition
Change from baseline in pharmacodynamic marker of PAPPA-1 inhibition.
Unit: ng/mL (or assay-specific unit).
Measured: Baseline to scheduled post-dose time points through Day 189 ±3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start10 Nov 2025
- Primary completion22 May 2027 (estimated)
- Study completion22 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase I, first-in-patient, randomized, single-blind, placebo-controlled study with a sequential MAD design in participants with autosomal dominant polycystic kidney disease (ADPKD). AZD1613 will be administered either subcutaneously or intravenously in up to 5 cohorts.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228364
- Sponsor's protocol ID
- D9050C00002
- Other IDs
- Identifier Number
- Acronym
- PIONEER-PKD
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07228364
- Acronym / sponsor ID
- PIONEER-PKD / D9050C00002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 May 2027 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a Phase I, first-in-patient, randomized, single-blind, placebo-controlled study with a sequential MAD design in participants with autosomal dominant polycystic kidney disease (ADPKD). AZD1613 will be administered either subcutaneously or intravenously in up to 5 cohorts.
| Arm | Type | Receives |
|---|---|---|
| Part A - Cohort A1 | Experimental | Drug: AZD1613 - Part A, Drug: Placebo - Part AParticipants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Part A - Cohort A2 | Experimental | Drug: AZD1613 - Part A, Drug: Placebo - Part AParticipants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Part B - Chinese Cohort | Experimental | Drug: AZD1613 - Part A, Drug: AZD1613 - Part B, Drug: Placebo - Part BParticipants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1613 - Part APart A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. | Drug | Part A - Cohort A1, Part A - Cohort A2, Part B - Chinese Cohort |
| Placebo - Part APart A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT. | Drug | Part A - Cohort A1, Part A - Cohort A2 |
| AZD1613 - Part BPart B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. | Drug | Part B - Chinese Cohort |
| Placebo - Part BPart B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT. | Drug | Part B - Chinese Cohort |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days)
Number of participants with at least one TEAE and SAE, including events leading to discontinuation or death; coded by system organ class and preferred term. Unit: participants.
Change From Baseline in Safety 12-Lead ECG QTcF
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in QT interval corrected using Fridericia's formula (QTcF) measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change From Baseline in Safety 12-Lead ECG PR Interval
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in PR interval measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change From Baseline in Safety 12-Lead ECG QRS Duration
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in QRS duration measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change From Baseline in Heart Rate (12-Lead Safety ECG)
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in heart rate measured on single 12-lead safety ECGs. Unit: beats per minute (bpm).
Change From Baseline in ALT
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in alanine aminotransferase. Unit: U/L.
Change From Baseline in AST
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in aspartate aminotransferase. Unit: U/L.
Change From Baseline in Total Bilirubin
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in total bilirubin. Unit: mg/dL.
Change From Baseline in Serum Creatinine
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in serum creatinine. Unit: mg/dL.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR; CKD-EPI 2021)
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in eGFR calculated using CKD-EPI 2021. Unit: mL/min/1.73 m².
Change From Baseline in INR
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in international normalized ratio- (INR). Unit: unitless.
Change From Baseline in Prothrombin Time (PT)
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in prothrombin time. Unit: seconds (s).
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in aPTT. Unit: seconds (s).
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR)
Time frame: Baseline (Day -1) and scheduled visits through Day 189 ±3 days; UACR as triplicate first-morning voids per visit
Change from baseline in UACR (geometric mean of triplicates at each visit). Unit: mg/g.
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in supine systolic blood pressure. Unit: mmHg.
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in supine diastolic blood pressure. Unit: mmHg.
Change From Baseline in Heart Rate (Vital Signs)
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in supine heart rate. Unit: bpm.
Change From Baseline in Body Temperature
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in oral body temperature. Unit: °C.
Change From Baseline in Respiratory Rate
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in respiratory rate. Unit: breaths per minute.
Change From Baseline in Oxygen Saturation (SpO2)
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change from baseline in pulse oximetry oxygen saturation. Unit: percent (%).
9 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of AZD1613
Time frame: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Area Under the Concentration-Time Curve to Last Quantifiable Concentration (AUClast) of AZD1613
Time frame: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of AZD1613
Time frame: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau) of AZD1613
Time frame: Over the dosing interval (τ = 28 days) at steady state; sampling through Day 189
Time to Maximum Observed Serum Concentration (Tmax) of AZD1613
Time frame: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Terminal Elimination Half-Life (t½) of AZD1613
Time frame: Intensive PK sampling from Day 1 through Day 189 per protocol schedule
Incidence of Anti-Drug Antibodies (ADA) to AZD1613
Time frame: Predose on dosing days and during follow-up through Day 189 ±3 days
ADA Titer to AZD1613
Time frame: Predose on dosing days and during follow-up through Day 189 ±3 days
Change From Baseline in PD Markers of PAPPA-1 Inhibition
Time frame: Baseline to scheduled post-dose time points through Day 189 ±3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1613 - Part A and AZD1613 - Part B in people with Autosomal Dominant Polycystic Kidney Disease, run by AstraZeneca at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, China, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.