A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
NCT07239570 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2025-11-20
Summary
Over 800 million people worldwide suffer from chronic kidney disease (CKD), which is associated with a high individual disease burden for those affected, multiple secondary diseases, frequent doctor contacts, and hospitalizations, but also outstanding costs for the health system and the solidarity community. Appropriate interventions are essential to prevent the development and progression of CKD. In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD. Sodium-glucose co-transporter 2 inhibitors, the non-steroidal mineralocorticoid receptor antagonist, finerenone, and the glucagon-like peptide-1 receptor agonist, semaglutide, have demonstrated albuminuria-lowering effects and kidney protection in people with CKD. Although these new pharmacological approaches show great promise, it is unclear how to optimally sequence and combine these therapies. In addition, the therapies are often not implemented due to treatment inertia and fear of adverse effects. This study aims to address this knowledge gap by utilizing a biomarker-guided treatment approach to reduce the decline in kidney function.
The aim of the CKD-bioMatch study is to evaluate the efficacy of a biomarker-targeted treatment approach versus standard of care in people with CKD and albuminuria. We hypothesize that a biomarker-targeted treatment approach is superior to standard of care at reducing estimated glomerular filtration rate (eGFR) decline in people with CKD.
Conditions
- Chronic Kidney Disease(CKD)
Interventions
- DRUG
-
Dapagliflozin 10 mg daily.
- DRUG
-
Semaglutide injection once weekly. Will be titrated every 4 weeks to the highest tolerable dose according to standard guidelines, aiming at 1 mg once weekly.
- DRUG
-
Finerenone 10-20 mg daily.
Sponsors & Collaborators
-
University Medical Center Groningen
collaborator OTHER -
Lund University
collaborator OTHER -
Instituto de Investigacion Sanitaria INCLIVA
collaborator OTHER -
Universitätsklinikum Hamburg-Eppendorf
collaborator OTHER -
Peter Rossing
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-20
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
Countries
- Denmark
- Germany
- Spain
- Sweden
Study Locations
More Related Trials
-
A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)
NCT04865770 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus
NCT05705271 ·Status: COMPLETED ·Phase: PHASE4
-
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
NCT07348484 ·Status: NOT_YET_RECRUITING
-
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
NCT05374291 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
NCT06555146 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes
NCT04889183 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
NCT07026539 ·Status: RECRUITING ·Phase: PHASE4
-
Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD
NCT07187830 ·Status: RECRUITING
-
Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study
NCT05897372 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
NCT05254002 ·Status: COMPLETED ·Phase: PHASE2
-
An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice
NCT05526157 ·Status: COMPLETED
-
An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
NCT05703880 ·Status: COMPLETED
-
Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study
NCT06954090 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE4
-
A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
NCT05348733 ·Status: ACTIVE_NOT_RECRUITING
-
Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial
NCT06094920 ·Status: COMPLETED ·Phase: PHASE4
-
Therapeutic Drug Use for CKD Patients
NCT05818995 ·Status: UNKNOWN
-
An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results
NCT05640180 ·Status: COMPLETED
-
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
NCT06094231 ·Status: TERMINATED ·Phase: NA
-
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
NCT03819153 ·Status: COMPLETED ·Phase: PHASE3
-
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
NCT05788276 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
NCT03036150 ·Status: COMPLETED ·Phase: PHASE3
-
Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease
NCT04258397 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
NCT05536804 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
GLUcose Transport and REnalPROtection in Chronic Kidney Disease
NCT05998837 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea
NCT07232537 ·Status: RECRUITING