Exploring clinical trials for kidney disease: What you need to know

• Clinical trials are central for advancing the treatment of kidney disease and chronic kidney disease (CKD).
• Clinical trials look at novel (new) ways to detect, treat, or prevent disease.
• Researchers also use clinical trials to look for ways to improve the quality of life and other aspects of care for people with chronic diseases.
• Participating in clinical trials helps researchers learn more about the disease and discover new treatment options.

Clinical trials are research studies that study the effectiveness of medical, surgical, or other interventions in humans. It takes roughly 12 years for a new prescription medicine to go from drug development to approval for use in the general population. Before a new medicine or treatment is approved for human use, researchers must first test it.

There are two main types of clinical research:

• Interventional studies or clinical trials: Researchers assign participants to one or more interventions (medicine or therapy). In some trials, participants are randomly assigned to the interventions.
• Observational studies: Researchers do not assign participants to interventions. Participants already take medicine or therapy as part of their healthcare or daily life, and researchers carefully look at the course of their disease or condition.

Clinical trials are run for many different reasons, such as:

• To determine if a new medicine or treatment is safe and effective for people to use.
• To study a new method of detecting or preventing a disease or condition.
• To learn how to safely administer a treatment in a population (such as children) where there is no previous testing.

There are typically four phases of a clinical trial. In each phase, the study progresses.

• Phase 1: Small clinical trial of 20-100 people. Researchers observe the patients closely to check how the medicines or therapy works in the human body. This phase aims to see if the treatment is safe and to determine the most appropriate dosage range. This phase may last for several months.
• Phase 2: This clinical trial phase includes 300 people with the condition or disease being studied. More information is gathered about the medicine or therapy’s safety and to observe how the disease or condition responds to treatment.
• Phase 3 includes 300-3,000 participants with the condition or disease being studied. In this phase, the medicine or therapy is compared to existing medicines or treatments to determine efficacy. Adverse reactions and side effects are also monitored.
• Phase 4: This phase includes thousands of participants who have the disease or condition. By phase 4, the FDA has approved the medicine or therapy for public use. Post-marketing monitoring occurs to check the therapy or medicine’s safety and efficacy in a large population.

In the U.S., clinical studies are regulated by the FDA. Each study is reviewed, approved, and monitored by an independent panel called the Institutional Review Board (IRB). The IRB ensures that participants understand that their rights, and that their safety and welfare are protected. It also ensures that the health risks involved in the study are reasonable compared to the possible rewards.

While no treatment is completely safe for everyone, there are many safeguards to ensure that the benefits of the clinical trial outweigh the possible risks.

Each clinical trial has an eligibility criteria describing who can or cannot join the study. The eligibility criteria depend on what is being studied in the trial. These criteria could include:

• Age
• Gender
• Healthy individuals (not having the health condition or disease that is being studied)
• Patient participants (having the health condition or disease being studied)

Before joining a clinical trial, talk to your healthcare provider about how the clinical trial may impact your current health status and if there is any benefit to joining.

Talk to your nephrologist or healthcare provider about joining clinical trials. They can help you make a referral to the research team working on the trial. You can also look through databases to find a clinical trial and learn how to participate. Some clinical trial databases include:

• Clinicaltrials.gov: This is a database of privately and publicly supported clinical studies worldwide.
• ResearchMatch.org: This NIH-funded resource is a free registry to keep you informed about any clinical studies that need participants matching your profile.
• CenterWatch: This database is a listing service that finds industry-sponsored clinical trials matching your disease that need participants.
• National Heart, Lung, and Blood Institute (NHLBI) Clinical Trials: This database lists studies sponsored by the NHLBI. You can search this database by disease or condition.

Panoramic Health is kidney care’s leading integrated provider group delivering the future of kidney care. Our mission is to improve patients’ outcomes by slowing disease progression and improving their quality of life.

One way we achieve this is by marrying clinical research with clinical implementation to redefine the standard of kidney care and keep people living longer and healthier with kidney disease.

In partnership with practices, Panoramic Health is enrolling patients in clinical trials for various indications such as:

• Resistant and uncontrolled hypertension
• Patients with excess weight who may also have heart disease or kidney disease
• Genetic conditions such as APOL1-Mediated Kidney Disease
• Diabetes
• IgA Nephropathy (IgAN)
• Lupus Nephritis
• ANCA Vasculitis

Are you interested in learning more about our clinical research capabilities or want to find out how you can partner with us? Contact [email protected] to connect!

*The content presented in this article is for informational use only and should not be construed as medical advice or replace the medical advice of a qualified physician.