New Research Study for People with Nephrotic Syndrome

Medical research studies help doctors and scientists learn about experimental drugs, including how well they work and how safe they are. Clinical trials may study the experimental drug (or study drug) by itself, and compare it to an approved medication or placebo.

There are common assessments that are performed during most clinical trials. Here is what you can expect during the Renovel study:

1. Read and sign the Informed Consent Form (ICF)

• The ICF explains the study in more detail. The study doctor will explain the information in the ICF and answer any questions. 
• You must sign the ICF before receiving any study medication or assessments. 
• Remember that taking part in the study is your choice. You can stop at any time. 

2. Confirm that you can join the study

•  You will visit the clinic 1 or 2 times to confirm you can join the study. This is called the screening period. 
• The screening period may last up to 2 months. 
• At your visits, the study doctor will ask you questions and take samples of your blood and urine.
• If you are receiving therapy for an NS relapse (such as steroids), you will taper off of the therapy during this time.

3. Take study medication 

• You will take the study medication by mouth 2 times every day for about 3 months. You will take it once in the morning and once at night.
• Depending on when you join the study, you may be randomly assigned to receive a placebo instead of the study medication.
  • A placebo looks like the study medication, but it does not have any active ingredients. 
  • A placebo helps researchers compare results between different people, to find out if the study medication has any specific effects. 

4. Visit the study clinic 

• You will visit the study clinic about 7 times for assessments. The assessments help measure how your body is responding to the study medication. Transportation via Uber Health will be available. 
• Assessments may include a physical exam, blood tests, a heart test, and others. You will also test your urine at home at least once per week.
• The study team will also give you a study diary to complete at home. You will use the diary to write down when you take the study medication and the results of home urine tests.

5. Go to the follow-up visit 

• At the end of the study, you will go to the study clinic for 1 follow-up visit. This visit will happen about 1 month after you stop taking the study medication.
• You will receive assessments at this visit, similar to your other visits.
• After this visit, your participation in the Renovel study will be complete.

Participation in the Renovel study will last about 6 months. 

You do not have to pay or have health insurance to sign up for a clinical trial. The trial drug and trial-related procedures are provided to participants at no charge to them or their health insurance company. Clinical trials often provide participants compensation (or a stipend) for their time and effort.

To find out if you’re eligible to participate in this study, take this quick pre-screening form here.

Yes, participant information is always kept secure and confidential, and will not be shared without your permission except as required by law.

Participating in a clinical trial is always voluntary. Even after signing up, you can leave at any point during the screening or trial process.

You do not have to pay or have health insurance to sign up for a clinical trial. The trial drug and trial-related procedures are provided to participants at no charge to participants or their health insurance companies.

Participating in a clinical trial may involve unforeseeable risks and does not guarantee that your symptoms improve. That being said, each study of a drug regulated by FDA must be reviewed and monitored by an institutional review board (IRB). Their role is to make sure that “the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities.” (clinicaltrials.gov) 

Before you even begin the formal screening process to enroll in a clinical trial, you will be given an “informed consent” form to fill out and sign. Giving your informed consent means that you have learned and understood all the aspects of the study and agree to participate in the research. Participating in a clinical trial is always voluntary and participants can withdraw consent at any time.  

In Part 1 of this study all participants will receive the study drug.

If at any time you no longer want to receive study treatment, you can stop treatment and leave the study no questions asked.