A Phase 1 interventional study of AZD1613 - Part A and Placebo - Part A in Autosomal Dominant Polycystic Kidney Disease, sponsored by AstraZeneca. Recruiting at 15 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
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.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
This study's planned enrollment of 40 is below the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Browse Polycystic Kidney, Autosomal Dominant studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
Drug: AZD1613 - Part A · Drug: Placebo - Part A
Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
Drug: AZD1613 - Part A · Drug: Placebo - Part A
Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.
Drug: AZD1613 - Part A · Drug: AZD1613 - Part B · Drug: Placebo - Part B
Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
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 Systolic Blood Pressure
Change from baseline in supine systolic blood pressure. Unit: mmHg.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 (%).
Time frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Maximum Observed Serum Concentration (Cmax) of AZD1613
Maximum observed serum concentration following subcutaneous or intravenous administration. Unit: µg/mL.
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
AUC from time zero to last quantifiable concentration. Unit: h·µg/mL (or day·µg/mL; align with bioanalytical report).
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
AUC from time zero extrapolated to infinity. Unit: h·µg/mL (or day·µg/mL).
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
AUC over the dosing interval at steady state. Unit: h·µg/mL (or day·µg/mL).
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 to reach Cmax after dosing. Unit: hours (h).
Time frame: 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).
Time frame: 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.
Time frame: 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).
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
Change from baseline in pharmacodynamic marker of PAPPA-1 inhibition. Unit: ng/mL (or assay-specific unit).
Time frame: Baseline to scheduled post-dose time points through Day 189 ±3 days
Plan to share: 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.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for May 2027, 18 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Polycystic Kidney, Autosomal Dominant →