You may pre-qualify for the SAPPHIRE Study if you:
We’re inviting you to take part in a study for individuals with Chronic Kidney Disease. All study-related visits, tests, and investigational drug will be provided at no cost. In addition, reimbursement for study-related travel may be provided. Health insurance is not required to participate.
The SAPPHIRE Study is evaluating the safety and effectiveness of an investigational drug in combination with an approved medication (allopurinol) in patients with Chronic Kidney Disease.
Chronic Kidney Disease (CKD) is a condition that is known as the gradual loss of kidney function over time. CKD includes conditions that damage your kidneys and decrease their ability to keep you healthy by removing excess fluid and waste products from the body. If kidney disease gets worse, wastes can build to high levels in your blood and make you feel sick. However, in over 60% of cases of those diagnosed with CKD, the two main causes of Chronic Kidney Disease are diabetes and high blood pressure.1
The symptoms of Chronic Kidney Disease can progress and worsen over time and may include:2
To diagnose Chronic Kidney Disease, a doctor may perform a variety of different tests such as blood tests, urine tests, medical imaging and biopsy, which is the removal of kidney tissue for testing. Treatment will usually depend on the underlying cause so that it can be slowed or controlled. If the kidneys become severely damaged, different options for end-stage kidney disease may need to be taken.
The SAPPHIRE Study is evaluating the safety and effectiveness of an investigational drug in combination with an approved medication (allopurinol) in CKD patients.
What happens if I sign up? We will match you to a research study location in your area that needs volunteers with Chronic Kidney Disease or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the SAPPHIRE Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
The SAPPHIRE Study is taking place at approximately 230 sites in approximately 13 countries, with a total of 725 patients participating.
Participants will receive all study-related visits, tests, and investigational drug from a dedicated medical team at no cost.
The study will include approximately 8 visits to a study clinic in your location over approximately 60 weeks. Thereafter, you will visit the clinic every 12 weeks until the last patient on the study has completed 60 weeks of taking the study drug. This may be up to more than 2 years on the study for the first patients.
Volunteers who qualify to take part in the study may receive reimbursement for study-related travel.
You may pre-qualify for the SAPPHIRE Study if you:
All study-related care is provided by a dedicated Medical Team.
A clinical research study (also called a clinical study) helps to answer important questions about an investigational drug – these may include if an investigational drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
The SAPPHIRE Study is a clinical research study for people with chronic kidney disease (CKD) who also have elevated levels of uric acid in their blood (a condition called hyperuricemia). This study is evaluating the safety and effectiveness of an investigational drug in combination with an approved medication (allopurinol) in CKD patients.
The study also compare the investigational drug to a placebo, which looks like the investigational study drug but does not contain any active medicine and is not designed to treat any disease or illness. It is designed to be compared with the investigational drug, to learn if the investigational drug has any real effect. Your study drug is assigned randomly. Neither you nor the study doctor will know which of the following you receive:
If you qualify and choose to join the SAPPHIRE Study, you will attend scheduled study visits periodically and take study drug each day.
The study staff will provide detailed instructions on what you need to do on your own.
These will include:
You will have 8 study visits over a period of about 60 weeks.
Thereafter, you will visit the clinic every 12 weeks until the last patient on the study has completed 60 weeks of taking the study drug. This may be up to more than 2 years on the study for the first patients. If you stop taking the study drug early, you will continue on the study and follow the original visit schedule without taking the study drug. At visits, the study doctor or staff will discuss your health with you, provide study drug, and conduct tests and assessments to monitor your health.
In the SAPPHIRE study, “study drug” may refer to any of the following:
Volunteers who qualify to take part in the study may receive reimbursement for study-related travel. Please discuss this with the study team when they contact you.
There is no cost to participate in the SAPPHIRE Study. If you qualify, all study-related visits, tests, and investigational drug will be provided at no cost. If you decide to take part:
The study team will be able to explain more about what the SAPPHIRE Study will involve, and it is up to you to decide if you want to take part. Participation is completely voluntary, and you may leave the study at any time for any reason. Before deciding to leave, you should consult the study doctor about continuing study visits after you stop taking the study drug. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
We match you to a site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.