Frequently asked questions

Clinical research studies involve testing all types of treatments, including investigational study drugs and medical devices. All investigational treatments have to be thoroughly researched before they are allowed to be used in medical care for people living with a particular condition. Investigational treatments are first tested in a laboratory, then clinical research studies take place to understand how these investigational treatments can affect people and their conditions.

Clinical research studies can take place in many locations, including hospitals, universities, doctors’ offices, and community clinics. The location depends on the researcher who is running the study in your area. Some study appointments may also be able to be completed at home.

While length of participation in the study may vary between participants, it’s estimated that the entire AMPLITUDE clinical research study will run for up to 4 years. There will be more appointments in the first few weeks of the study. After that, you will have an appointment scheduled about every 8 weeks. The study doctor and their staff will share more information about the number of visits and time required for you to take part.

If you take part in the AMPLITUDE clinical research study, you will either be given the investigational study drug or a placebo. A placebo looks exactly the same as the investigational study drug, but has no active ingredients and is not intended to have a medical effect. Placebos are used so that researchers can tell if the investigational study drug is having an impact. They are an important part of the study, and you will still be making a difference in chronic kidney disease research if you take the placebo.

No, there are no animal-derived ingredients in the investigational study drug or the placebo.

Around 466 people will take part in this clinical research study.

Some of the assessments and tests that may be included in your appointments include:

• Questionnaires about yourself and your health
• Physical exams (like weight and blood pressure measurements)
• Heart assessments (ECG)
• Blood and urine (pee) samples
• Pregnancy tests (if you are able to get pregnant)

Full details of the tests and procedures involved at study appointments will be explained to you before you begin the clinical research study.

Your responsibilities will be explained to you by your clinical research study team, and will include:

• Attending all clinical research study appointments as scheduled and complying with the study procedures and tests.
• Telling the study doctor about your current medical condition(s) and medical history, and letting your study doctor know about any prescription, over-the-counter, or herbal supplements you are taking or have taken recently.
• Telling your study doctor immediately if you begin to feel unwell or experience any side effects, even if you do not think it’s related to the clinical research study.
• Letting your study doctor know if you change address or phone number, so they can stay in contact with you during the study.

There may be some risks to taking part, either from the investigational study drug or from some of the assessments and procedures. Before taking part, you will be provided with an informed consent form that describes the full details of the risks involved. Your study doctor and study staff will also be able to answer any questions that you may have.

No one knows if taking part in the AMPLITUDE clinical research study will help you. The information obtained from this research may provide helpful information that could ultimately help people with chronic kidney disease.

You can stop participating in the AMPLITUDE clinical research study at any time by informing your study doctor — this is called the right to withdraw. The study doctor may also stop you from taking part at any time for various reasons, which will be explained further to you before you take part.

You may be compensated for your study-related time. You will be given full details as to how much you may be reimbursed by a member of the study team.

The tests or visits associated with the study will be of no cost to you. You may be reimbursed for expenses needed to participate in the clinical research study, like transportation and meals. You will be given full details as to how much you may be reimbursed by a member of the study team.