A clinical trial is a research study involving human participants that investigates the safety and effectiveness of potential new treatments, procedures, or diagnostic methods, or evaluates new ways of using existing treatments. All potential new treatments must undergo testing in clinical trials and be approved by the FDA before they can be prescribed by doctors.
A Phase 3 clinical trial is a late-stage study that involves a larger group of participants than earlier phase clinical trials. It is conducted to confirm the effectiveness of a potential treatment, monitor its side effects, and compare it to commonly used treatments. This phase helps gather more research information to ensure the potential treatment is safe and effective. This is the last phase before FDA approval.
Participating in a Phase 3 clinical trial can provide access to potential new treatments that have shown promise in earlier studies, but are not yet approved and available to the public. Participants often receive close monitoring and care from the study doctors and research team. It also allows individuals to contribute to medical research that may benefit others in the future. Diverse participation in clinical trials can help ensure that potential new treatments work for everyone.
Chronic kidney disease (CKD) is a condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. Diabetes, on the other hand, is a condition where the body either doesn’t produce enough insulin or can’t use insulin effectively, leading to high blood sugar levels.
Chronic kidney disease (CKD) and diabetes are closely linked. When people have diabetes, their bodies have trouble managing sugar levels in their blood. High blood sugar can damage many parts of the body, including the kidneys, heart and blood vessels. Over time, kidney damage can lead to CKD. It is important for people with diabetes to keep their blood sugar under control and have regular check-ups to catch any early signs of kidney problems. By managing their diabetes well, they can help protect their kidneys and lower the risk of CKD.
To help prevent chronic kidney disease (CKD), it’s crucial to manage risk factors such as high blood pressure and diabetes. This can be achieved through a healthy diet, regular exercise, maintaining a healthy weight, and avoiding smoking. Regular check-ups with your primary care provider can also help detect and manage early signs of kidney disease.
Treatment options for CKD include lifestyle changes, medications to control blood pressure, blood sugar, serum cholesterol, and in advanced cases, dialysis or kidney transplant. The goal of treatment is to slow the progression of the disease and manage symptoms. Currently, there is no cure for CKD.
The ProKidney clinical trial will evaluate the safety and effectiveness of rilparencel in people with type 2 diabetes and advanced chronic kidney disease (CKD). The study will help determine if rilparencel can stabilize kidney function.
Rilparencel is an investigational cell-based therapy made from a person’s own kidney cells. The patient’s cells are collected from a kidney biopsy, expanded and selected in a cell manufacturing facility, and then injected back into the kidneys. The goal of using rilparencel is to stabilize kidney function.
Participating in this trial may provide you with access to a new potential treatment for CKD that is not yet available to the public. Additionally, your participation could contribute to medical research that may benefit others with similar conditions in the future.
Your safety is a top priority. To ensure your safety, we will conduct multiple tests, such as regular blood tests, urine tests, and imaging studies to monitor your health over the course of the trial. You will also be closely monitored by the study team throughout the trial. If you experience any side effects or health issues, they will be promptly addressed. There is also an independent oversight safety committee that reviews our safety database.
As with any medical procedure, there are potential risks. These include possible side effects associated with the kidney biopsy and rilparencel injections, such as pain, bleeding, or infection at the injection site. The study team will discuss all potential risks with you before you decide to participate.
Your personal information will be kept confidential. Only the study team and authorized personnel will have access to your data. Your information will be coded to protect your identity, and any published results will not include your name or other identifying details.
You can take our pre-screening survey to indicate interest in participating in the clinical trial. Our case management partners at Carebox will review your survey responses. If there is a high enough likelihood you are eligible to participate in the trial, someone from Carebox will contact you to ask further questions and connect you with a site study coordinator. The study site coordinator will arrange a time for you to visit the site and conduct additional screenings to determine eligibility.
Someone from CareBox will contact you via your preferred method of communication within 48 hours.
Someone from CareBox will contact you via your preferred method of communication within 48 hours.
Yes, someone from MDGroup, our partner organization who helps arrange transportation support, will contact you if you need it.
As a participant in this trial, you will participate in different tests and procedures, including blood and urine tests. If you are in the group that receives the investigational treatment, you will undergo a kidney biopsy and injections into the kidney. These tests and procedures will be performed in hospitals or specialty clinics and will be closely monitored by the study doctors and research team. You will need to make several visits to the study center and may also need to make follow-up visits for up to five years. If you are in the group that doesn’t receive the investigational treatment, called a placebo or sham group, you will still go through other parts of the study that seem similar to those of participants that are in the group that receives the investigational treatment. You will also have regular check-ups, just like the people who are getting the investigational treatment.
Possible side effects of the procedures performed in this trial include pain after the biopsy and injections, bleeding around the kidney, breathing issues, nausea, and blood pressure changes. The study doctors and nurses will monitor you closely for any side effects and provide appropriate care if needed.
Double-blinded means that none of the participants or lead investigator know who is receiving the investigational treatment and who is receiving a placebo or simulated treatment. This is considered the “gold standard” of research because it helps to remove any outside factors or bias that may influence the study results and makes the results more reliable and accurate. Other team members, such as the research coordinators and doctors who perform biopsies and injections are “unblinded,” meaning they will know who is in the investigational or the sham group, but they are not allowed to disclose this information to the participants, other study staff or lead investigators.
Biopsy and Injection Procedures
Safety Assessments and Management
Yes, participation in the trial is completely voluntary. You can choose to withdraw at any time without giving a reason. Withdrawing from the trial will not affect your standard medical care.
If you have any questions or need more information, you can contact the study doctor or research team at the phone number and address provided in the consent form.
To stay informed about the results of the trial, you can sign up for our newsletter. When the study is complete, we will send you updates on findings from the study. Additionally, if there are any severe adverse events, the study team will contact you directly.
The PROACT 1 clinical trial cannot guarantee any direct benefits to individual participants. However, your participation may contribute to valuable research that could benefit others in the future.
The ProKidney clinical trial is a Phase 3 study to test a
new intervention called rilparencel.
