Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD1613 - Part B
AZD1613 · 1 trial · 1 indication
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 QT interval corrected using Fridericia's formula (QTcF) measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change from baseline in PR interval measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change from baseline in QRS duration measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change from baseline in heart rate measured on single 12-lead safety ECGs. Unit: beats per minute (bpm).
Change from baseline in alanine aminotransferase. Unit: U/L.
Change from baseline in aspartate aminotransferase. Unit: U/L.
Change from baseline in total bilirubin. Unit: mg/dL.
Change from baseline in serum creatinine. Unit: mg/dL.
Change from baseline in eGFR calculated using CKD-EPI 2021. Unit: mL/min/1.73 m².
Change from baseline in international normalized ratio- (INR). Unit: unitless.
Change from baseline in prothrombin time. Unit: seconds (s).
Change from baseline in aPTT. Unit: seconds (s).
Change from baseline in UACR (geometric mean of triplicates at each visit). Unit: mg/g.
Change from baseline in supine systolic blood pressure. Unit: mmHg.
Change from baseline in supine diastolic blood pressure. Unit: mmHg.
Change from baseline in supine heart rate. Unit: bpm.
Change from baseline in oral body temperature. Unit: °C.
Change from baseline in respiratory rate. Unit: breaths per minute.
Change from baseline in pulse oximetry oxygen saturation. Unit: percent (%).
| Arm | Type | Description |
|---|---|---|
| Part A - Cohort A1 | EXPERIMENTAL | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Part A - Cohort A2 | EXPERIMENTAL | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Part B - Chinese Cohort | EXPERIMENTAL | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Name | Type | Description |
|---|---|---|
| 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. |
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)....
AZD1613 is being developed for the treatment of autosomal dominant polycystic kidney disease, a genetic kidney disorder. It is an investigational small molecule and has not been approved for any use. Clinical evaluation is currently limited to a Phase 1 study in adults with the condition.
AZD1613 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company is the sponsor of the Phase 1 clinical program evaluating the compound in autosomal dominant polycystic kidney disease.
AZD1613 is in Phase 1 clinical development. The program consists of a single Phase 1 trial that is currently recruiting participants. Because it remains investigational, AZD1613 has not received FDA approval and is not available as a marketed therapy.
AZD1613 is being studied in the Phase 1 trial NCT07228364, titled Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease. The trial is recruiting and plans to enroll 40 adults across sites in the United States, China, and the United Kingdom.
Yes. AZD1613 Part A and AZD1613 Part B are alternative designations for the same compound, AZD1613. These labels refer to the separate portions of the Phase 1 study evaluating the drug in adults with autosomal dominant polycystic kidney disease.
The Phase 1 trial NCT07228364 is a randomized, double-blind, controlled study evaluating the safety, tolerability, and pharmacokinetics of AZD1613 in adults with autosomal dominant polycystic kidney disease. It plans to enroll 40 participants aged 18 years and older and is currently recruiting.