A Trial to Evaluate an Investigational Drug called “REACT” as Treatment for People with Type 2 Diabetes and Chronic Kidney Disease

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Drugs that enter Phase 3 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug already, usually in up to several hundred people. Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include thousands of people. Phase 3 trials are used to collect even more information about how safe a drug is and how well it works.

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “See if you may qualify” button.

Renal autologous cell therapy (REACT) is made using kidney cells taken from a person’s own body. Certain cells are selected and grown, then injected back into that person’s kidneys. The clinical study team will educate patients on any possible risks and benefits during the enrollment process.

There will be no cost to you for taking part in this study. You will be provided with all injections, examinations and medical care related to the study at no cost to you. People who qualify and choose to join may be compensated for study-related time and procedure visits, and may be reimbursed for travel expenses, depending on the study site and local regulations. Please speak to the study doctor for more information.

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements.

The trial doctor and other site staff will collect your personal information. This may include:

• Your name, address, and telephone number.
• Your age, sex, and ethnic and racial background.
• Your lifestyle information.
• Your medical history details.
• Your trial treatment and your response to these treatments.
• Data resulting from testing your biological samples.