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NCT05457283 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
A Phase 3 study of Chronic Kidney Disease and Children, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05457283 is a Phase 3 study of Chronic Kidney Disease and Children that is actively recruiting participants, run by Bayer. The registered enrollment target is 100 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT05457283, a Phase 3 study of Chronic Kidney Disease and Children, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 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 help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). 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 impair the ability of the kidneys to work 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 how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which
Conditions Studied
Interventions
- DRUG Finerenone (Kerendia, BAY94-8862)
Study Locations (20)
California
- Cedars-Sinai Samuel Oschin Cancer Center - 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
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
Maryland
- The Charlotte R. Bloomberg Children's Center Building - Nephrology - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2029-02-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05457283
The ClinicalTrials.gov registry entry for NCT05457283 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (97% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 1 intervention - of which Finerenone (Kerendia, BAY94-8862) is the first listed.
NCT05457283 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Ohio, Arizona.
Frequently Asked Questions
What is clinical trial NCT05457283 about?
NCT05457283 is a clinical study titled "A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age 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 NCT05457283?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2022-11-08. Estimated completion is 2029-02-27.
What conditions does trial NCT05457283 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Children, Proteinuria.
What interventions are being tested in trial NCT05457283?
The interventions under investigation include: Finerenone (Kerendia, BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT05457283?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05457283 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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