CLINICAL TRIAL ALERT
As you can imagine, COVID-19 is affecting every aspect of life, including clinical trial research studies. AAKP wants to provide some guidance to kidney patients interested in participating in clinical studies and those already participating in clinical studies:
- If you interested in a clinical trial, please check with the study Sponsor (Company conducting the trial), study website, or a study trial site to find out if the study is enrolling patients. Many clinical trials are still enrolling new patients and have taken appropriate measures to protect study participants and manage study conduct during the COVID-19 pandemic; such as implementing home visits by trained nursing staff, telehealth check-ins with physicians, and shipping supplies and/or the investigational study drug. Other clinical trials may have a hold on enrolling new patient participants while modifications are being made to accommodate the COVID-19 situation. If a trial you are interested in is accepting new patients, please consider taking part! If a trial you are interested in is not accepting new patients, please continue to check back with them directly to determine when they have opened the trial back up to new participants.
- If you are already in a clinical trial, thank you for doing this! Your contributions are very important to the long-term advancements in patient care. Please continue to take your study drug as prescribed. Also, stay in close contact with your study center for study specific instructions and to confirm what their plans are for you. Some study centers may be able to continue to see you and resupply your study drug. Other sites may not be able to see you, but may be able to ship your study drug to you.
AAKP’s role in Clinical Trials and Market Research
AAKP supports innovation in the kidney space. We are actively involved in market research – to share the patient voice and experience with renal companies and clinical trials – to create more and better treatment options for kidney patients, so they can achieve their aspirations.
You may have heard the term “clinical trials” but wonder what that means. Is a clinical trial something you can participate in? What do you need to do to get started? We have pulled together some information that you might find helpful as you decide whether you would like to participate in a clinical trial.
Clinical Trials and Market Research Opportunities
Below is a list of the Clinical Trials and Market Research opportunities that AAKP is partnering to raise awareness of. You can also use the search tool below to be matched to even more opportunities.
| Name | Description | Learn More |
|---|---|---|
| APOLO1 Gene Study | The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an investigational medication in individuals with APOL1-dependent FSGS. The word “investigational” means this medication is not yet approved for use by the Food and Drug Administration (FDA) in the United States or other regulatory agencies in the UK, Europe, or elsewhere. We are looking for adults between the ages of 18 and 60 with a high-risk APOL1 gene variation and biopsy-confirmed FSGS to participate in this clinical research study. Testing for the APOL1 gene is included in this clinical study. | Click here to read more about this opportunity. |
| PROTECT Study | Retrophin is now enrolling patients in the PROTECT Study, a global Phase 3 clinical study investigating the safety of sparsentan and the effects it has on the amount of protein in the urine (proteinuria) and on kidney function in patients with IgAN. | Click here to read more about this opportunity. |
| DUPLEX Study | Retrophin is now enrolling patients in the DUPLEX Study, a global Phase 3 clinical study investigating the safety of sparsentan and the effects it has on the amount of protein in the urine (proteinuria) and on kidney function in patients with FSGS. | Click here to read more about this opportunity. |
| ARENA 2 Study for primary dRTA | This clinical study is enrolling patients between 6 months and 65 years of age who have been diagnosed with distal renal tubular acidosis. The ARENA-2 trial is studying how well the medication ADV7103, taken twice a day, treats dRTA. | Click here to read more about this opportunity. |
| FALCON Study | FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with ADPKD. The investigational drug, study-related procedures, and doctor visits will be provided at no cost. Visit PKDstudy.com for more information. | Click here to read more about this opportunity. |
| Emerald Study | Ongoing Pediatric Clinical Trial. Parents – do you have a child between the ages of 2 and 12 with kidney disease who also struggles to manage high blood potassium levels? | Click here to read more about this opportunity. |
