Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
The Proact study is looking into a new treatment called REACT (or rilparencel) for individuals in the UK who have both type 2 diabetes and long-term kidney problems. This treatment involves injections into the kidney. The main aim is to understand if these injections are safe and effective in improving kidney health. Some participants will receive the actual treatment, while others will have a 'sham' procedure that mimics the treatment but doesn't involve the active substance or actual injections, helping researchers compare results fairly. The study is in its final main phase of testing, meaning it's building on earlier research.
At a glance
What is this study about?
The Proact study is designed to explore a new way of treating people who have both type 2 diabetes and chronic kidney disease. These two conditions are often linked, and chronic kidney disease can be a serious complication of diabetes. The potential new treatment, called REACT (or rilparencel), involves giving injections directly into the kidney.
Researchers want to find out two main things: firstly, is REACT a safe treatment? And secondly, how well does it work to improve or protect kidney function? The study will compare patients who receive the REACT injections with a group who receive a 'sham' procedure. This sham procedure is designed to look and sound like the real treatment but doesn't involve the actual medicine or injections. This is a common and important way in medical research to ensure that any observed benefits are truly due to the treatment being studied and not just the expectation of receiving treatment.
This study is in 'Phase 3,' which means it's a large-scale trial, usually the last step before a treatment might be considered for wider use, if proven safe and effective. It's a 'blinded' study, meaning neither the participants nor their doctors will know whether they are receiving the actual REACT treatment or the sham procedure. This helps keep the results unbiased and accurate.
Key takeaways
- Investigating a new injection treatment (REACT/rilparencel) for type 2 diabetes and chronic kidney disease.
- Aims to assess safety and effectiveness in protecting kidney function.
- Includes both actual treatment and 'sham' procedures for comparison.
- Participants will be closely monitored by medical professionals.
- Participation involves kidney procedures and regular follow-up visits.
- Study is in a late stage of research (Phase 3).
Who may be eligible?
To be considered for this study, you would typically need to be between 30 and 80 years old and have a confirmed diagnosis of both type 2 diabetes and long-term kidney disease. Your blood sugar control (measured by HbA1c) should be at 9.5% or lower, and your blood pressure should be well-controlled.
It's important that you are already, or could be, considered for certain standard diabetes medications (like SGLT2 inhibitors) and are on a suitable dose of blood pressure medication (like ACE inhibitors or ARBs), unless you cannot take them for medical reasons. You must also be able to temporarily stop any medications that might increase your risk of bleeding around the time of the study procedures.
There are also reasons why someone might not be able to join, such as having type 1 diabetes, having had an organ transplant, or if your kidney disease has a different known cause. People with recent heart attacks, strokes, or certain severe heart conditions, as well as those with some types of cancer or specific infections, would also not be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 30 and 80 years old?
- Do you have a diagnosis of both type 2 diabetes and chronic kidney disease?
- Is your blood sugar (HbA1c) currently 9.5% or lower?
- Do you have well-controlled blood pressure (140/90 or lower)?
- Are you able to temporarily stop medicines that increase bleeding risk if needed?
- Do you have type 1 diabetes, a recent heart attack/stroke, or specific other medical conditions?
What does participation involve?
If you are eligible and choose to take part, the study will involve several visits to the clinic over a period of time, until the study officially ends for all participants. Initially, you'll be assigned by chance (like flipping a coin) to one of two groups. If you're in one group, you'll have a kidney biopsy followed by an injection of rilparencel into that kidney, and then about 12 weeks later, a second injection into the other kidney. If you're in the other group, you'll have 'sham' procedures that mimic the sounds and activities of a biopsy and injections, but without the actual procedure or medication.
Throughout the study, you'll have regular check-ups, blood tests, and other assessments to monitor your health, kidney function, and the effects of the treatment. You'll need to agree to follow all study instructions and be able to temporarily stop certain medications that could increase bleeding risk for specific periods before and after any procedures.
Potential risks and benefits
Locations (95)
- Nephrology ConsultantsVerified postcodeHuntsville, United States· Recruiting
- University of ArizonaVerified postcodeTucson, United States· Recruiting
- Amicis Research CenterVerified postcodeBeverly Hills, United States· Active not recruiting
- Paradise Clinical Research Group LLCVerified postcodeGlendora, United States· Withdrawn
- Kidney Consultants Medical GroupVerified postcodeGranada Hills, United States· Active not recruiting
- IMD Clinical TrialsVerified postcodeHuntington Park, United States· Recruiting
- Advanced Medical Research, LLCVerified postcodeLakewood, United States· Recruiting
- Medicine and Nephrology AssociatesVerified postcodeLos Alamitos, United States· Recruiting
- Academic Medical Research InstituteVerified postcodeLos Angeles, United States· Recruiting
- Southern California HospitalVerified postcodeLos Angeles, United States· Recruiting
- Allameh Medical CorporationVerified postcodeMission Viejo, United States· Completed
- Golden Pacific Nephrology Medical Clinic IncVerified postcodeMonterey Park, United States· Recruiting
Common questions
What is chronic kidney disease?
Chronic kidney disease (CKD) means your kidneys are damaged and can't filter blood as well as they should, leading to waste build-up in your body. It's a long-term condition.
What is a 'sham' procedure?
A 'sham' procedure looks and feels like the real treatment but doesn't involve the actual medicine or intervention. It helps researchers compare results fairly, ensuring any benefits are truly from the treatment.
Will I know if I'm getting the actual treatment or the sham?
No, this is a 'blinded' study, meaning neither you nor your doctors will know which group you are in. This helps make the study results more reliable.
What does a kidney biopsy involve?
A kidney biopsy is a procedure where a small sample of kidney tissue is taken, usually with a needle, to be examined under a microscope. It's done to diagnose or understand kidney conditions.
How long will the study last for me?
You will be followed from the start of your participation until the overall study officially concludes for all participants, which means the duration can vary but will be long-term.
How to find out more
ProKidney Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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