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NCT05196035 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria
A Phase 3 study of Chronic Kidney Disease and Proteinuria, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
- 20
- Study locations
NCT05196035 is a Phase 3 study of Chronic Kidney Disease and Proteinuria that is actively recruiting participants, run by Bayer. The registered enrollment target is 219 participants, below the 3,205-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT05196035, a Phase 3 study of Chronic Kidney Disease and Proteinuria, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in i
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Finerenone (Kerendia, BAY94-8862)
Study Locations (20)
California
- Cedars-Sinai Medical Center - Nephrology - Los Angeles
- Lucille Packard Children's Hospital Stanford - Pediatric Nephrology - Palo Alto
- Rady Children's Hospital San Diego - Cardiology - San Diego
Ohio
- Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension - Cincinnati
- Cleveland Clinic | Pediatric Nephrology - Cleveland
Ciudad Auton. de Buenos Aires
- Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department - Ciudad Autonoma de Buenos Aire
- Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department - Ciudad Autonoma de Buenos Aire
Arizona
- Phoenix Children's Hospital | Main - Transplant Department - Phoenix
District of Columbia
- Children's National Hospital - Nephrology - Washington D.C.
Florida
- Memorial Transplant Institute - Pediatric Nephrology - Hollywood
Georgia
- Emory University Hospital/Children's Healthcare of Atlanta - Nephrology - Atlanta
Iowa
- University of Iowa Health Care Medical Center - Nephrology - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05196035
The ClinicalTrials.gov registry entry for NCT05196035 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,205-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (93% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05196035 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Ohio, Ciudad Auton. de Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT05196035 about?
NCT05196035 is a clinical study titled "A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria". Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children wit...
What is the current status of trial NCT05196035?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2022-03-28. Estimated completion is 2027-08-31.
What conditions does trial NCT05196035 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Proteinuria.
What interventions are being tested in trial NCT05196035?
The interventions under investigation include: Placebo (DRUG), Finerenone (Kerendia, BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT05196035?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05196035 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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