A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) (NCT07220083)
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants
๐ฉบ Plain-English Summary (8th-Grade Level)
PODOMOUNT-pFSGS This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS. Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS. Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can join: Review the eligibility criteria below.
Location: Alabama Kidney Research โ Alabaster, Alabama
Age range: 12 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (306 Sites)
Showing the first 25 of 306 sites.
- Alabama Kidney Research โ Alabaster, Alabama
- Apogee Clinical Research โ Huntsville, Alabama
- Southwest Kidney Institute โ Surprise, Arizona
- West Coast Kidney Institute โ Fremont, California
- Kidney Disease Medical Group โ Glendale, California
- Amicis Research Center - Balboa โ Granada Hills, California
- Valiance Clinical Research โ Huntington Park, California
- Academic Medical Research Institute - Glendale โ Los Angeles, California
- Kaiser Permanente - Los Angeles Medical Center โ Los Angeles, California
- University of California Los Angeles โ Los Angeles, California
- Valley Renal Medical Group - Northridge โ Northridge, California
- Shasta Critical Care Specialists โ Redding, California
- North America Research Institute โ San Dimas, California
- Kaiser Permanente - French Campus โ San Francisco, California
- Valiance Clinical Research-Tarzana-68237 โ Tarzana, California
- National Institute of Clinical Research - Victorville โ Victorville, California
- Kidney Associates of Colorado - Denver โ Denver, Colorado
- Colorado Kidney Care โ Denver, Colorado
- George Washington University Medical Faculty Associates โ Washington D.C., District of Columbia
- Florida Kidney Physicians - Boca Raton โ Boca Raton, Florida
- Florida Kidney Physicians, LLC - Fort Lauderdale โ Fort Lauderdale, Florida
- Total Research Group, LLC โ Miami, Florida
- CTR Oakwater, LLC โ Orlando, Florida
- Florida Kidney Physicians - Riverview/Brandon โ Riverview, Florida
- Emory Children's Center โ Atlanta, Georgia
๐ Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Focal Segmental Glomerulosclerosis
- Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure โ Boston, Massachusetts
- An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases โ Bethesda, Maryland
- Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children โ Loma Linda, California
- Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBERยฎ LA-15 System โ Loma Linda, California
- Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases โ Los Angeles, California
- A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS) โ Chula Vista, California
Explore by condition: All Focal Segmental Glomerulosclerosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.