Autosomal Dominant Polycystic Kidney Disease study: AZD1613 - Part A vs AZD1613 - Part B
Official title Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT07228364
What this study is testing
What is AZD1613 - Part A?
An investigational medicine being studied for autosomal dominant polycystic kidney disease (ADPKD).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well the drug AZD1613 is, and how it moves through the body when given under the skin or through a vein.
- Who it's for
- Adults who have autosomal dominant polycystic kidney disease.
- What's involved
- Participants will receive AZD1613 either by injection under the skin or into a vein, and will have blood tests and safety checks.
- Time commitment
- The study will last a few weeks, with several clinic visits for injections, blood draws, and safety monitoring.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally.
- 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
You likely can't join if
- As judged by the investigator, any evidence of cardiac, vascular, and other renal conditions which in the investigator's opinion makes it undesirable...
- 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...
- Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator.
See the full eligibility 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).
- Females are to be of non-childbearing potential
- 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.
- 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 \ 100 bpm at screening. Patients taking anti-hypertensive medication should be on a stable treatment regimen of antihypertensive therapy for at least 30 days...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Lenexa, Kansas, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Chengdu, China
- Hangzhou, China
- Nanjing, China
- Xiamen, China
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jacksonville, Florida, United States; Orlando, Florida, United States; Lenexa, Kansas, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Chengdu, China and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.