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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For countries that are enrolling pediatric patients: 12 to 75 years old at the time of signing the informed consent. For countries that are not enrolling pediatric patients: 18 to 75 years old at the time of signing the informed consent.
ACEi/ARB therapy at maximum tolerated dose stable for at least 4 weeks prior to screening. ACEi/ARB dose should remain stable over the course of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective in treating Alport Syndrome and FSGS.
Who is the study for?
This trial is for patients with Alport Syndrome or Focal Segmental Glomerulosclerosis who have uncontrolled proteinuria despite ACE/ARB therapy. Participants must be willing to follow study procedures and use contraception. Exclusions include uncontrolled diabetes, hypertension, recent investigational drug use, organ transplant recipients, active infections including COVID-19, and certain medication restrictions.Check my eligibility
What is being tested?
The trial is testing R3R01's safety, tolerability, efficacy, and how the body processes it in patients with Alport Syndrome or Focal Segmental Glomerulosclerosis. It's an open-label Phase 2 study where all participants will receive the experimental drug without a placebo comparison.See study design
What are the potential side effects?
Potential side effects of R3R01 are not specified here but typically could include reactions at the injection site if applicable, gastrointestinal symptoms like nausea or diarrhea, potential kidney function changes given the patient population involved in this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 75 years old, or I am between 18 and 75 if my country does not enroll children.
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I have been on a stable dose of ACEi/ARB for at least 4 weeks.
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My kidney disease (FSGS) is confirmed by biopsy or linked to a genetic mutation.
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My kidney function is within the required range.
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My kidney function is good based on a specific test.
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I am at least 12 years old in a country enrolling children, or 18 otherwise.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess change in urine creatinine protein ratio
Incidence of adverse events (Safety and Tolerability)
Secondary outcome measures
Change in quality-of-life assessment from baseline to end of treatment and to the end of the follow-up period by cohort for adults
Change in quality-of-life assessment from baseline to end of treatment and to the end of the follow-up period by cohort for children
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 3 (Focal Segmental Glomerulosclerosis Patients)Experimental Treatment1 Intervention
R3R01 administered orally as 200 mg tablets twice daily for the 84 days.
Group II: Cohort 2 (Alport Syndrome Patients)Experimental Treatment1 Intervention
R3R01 administered orally as 200 mg tablets twice daily for 84 days.
Find a Location
Who is running the clinical trial?
River 3 Renal Corp.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use condoms and will inform the investigator if my partner becomes pregnant during the study.My condition did not improve or had side effects after long-term steroid use.My Alport Syndrome (AS) diagnosis is confirmed by genetic testing or kidney biopsy.I am between 12 and 75 years old, or I am between 18 and 75 if my country does not enroll children.I have been on a stable dose of ACEi/ARB for at least 4 weeks.My ACE inhibitor or ARB dose has been stable for at least 28 days.My last Rituximab treatment was over 120 days ago and my CD20 cell count is normal.I've been on a stable dose of another antibody treatment for over 120 days, and my doctor thinks it's safe to start the study drug.I had COVID symptoms within the last 3 months but have been symptom-free for 2 weeks, though I still test positive.I have Alport Syndrome, either X-linked or autosomal inherited.My kidney disease (FSGS) is confirmed by biopsy or linked to a genetic mutation.I have had an organ transplant, am waiting for one, or might get one in the next 6 months.I do not have the collapsing variant of FSGS according to my kidney biopsy.I had my last COVID vaccine dose at least a week ago.I am currently taking bardoxolone, rituximab, cyclophosphamide, abatacept, or sparsentan.I haven't taken any experimental drugs in the last 30 days or 5 half-lives.I have a genetic condition that affects how my body processes certain sugars.I do not have any active or uncontrolled infections, including COVID.I am HIV positive.I haven't taken sparsentan in the last 30 days but have been on a stable dose of SGLT2 inhibitors for 3 months.I have Focal Segmental Glomerulosclerosis.My kidney function is within the required range.My FSGS is caused by another health condition like obesity or an autoimmune disorder.My kidney function is good based on a specific test.I haven't taken Rituximab, cyclophosphamide, or abatacept in the last 120 days.I or my partner will avoid pregnancy during and for 90 days after the study.I haven't taken Bardoxolone or sparsentan in the last 30 days, but I may be on a stable dose of SGLT2 inhibitors for 3 months.I am using or agree to use effective birth control if I can have children.I have not had cancer, except for treated skin cancer, in the last 5 years.I only have Alport Syndrome and no other kidney diseases.My blood pressure is not controlled and is very high.I am at least 12 years old in a country enrolling children, or 18 otherwise.My liver function is not severely impaired, except for issues caused by kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 (Alport Syndrome Patients)
- Group 2: Cohort 3 (Focal Segmental Glomerulosclerosis Patients)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this clinical trial recruited thus far?
"Affirmative. According to clinicaltrials.gov, this research program is currently recruiting participants and was first published on June 15th 2022. Subsequent updates were made on August 15th 2022, with the goal of enlisting 50 volunteers from 10 different locations."
Answered by AI
How many health care facilities are administering this trial?
"Currently, this clinical investigation is recruiting at 10 sites. These include Miami, Cleveland and Ann Arbor in addition to other locations. To reduce travel burdens during the trial period, participants are encouraged to select the nearest site for enrollment."
Answered by AI
Are there any open spots for enrollment in this medical trial at present?
"Affirmative. The medical trial, which was posted in mid-June of 2022, is currently recruiting volunteers with an aim to bring on 50 patients from 10 different sites."
Answered by AI
Has R3R01 gone through the necessary regulatory processes to be accepted by the FDA?
"With regard to safety, R3R01 receives a score of 2 due to evidence gathered in the Phase 2 trial which suggests it is secure but has yet to be evaluated for efficacy."
Answered by AI
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