Chronic Renal FailurePhase 2DapaBalci-LeapNCT05884866
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease.
A Phase 2 study testing Dapagliflozin 10mg Tab, Balcinrenone 50mg Capsule and Balcinrenone 100mg Capsule in people with Chronic Renal Failure and Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis, run by Klinikum Nürnberg at 2 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Renal Failure, Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis, Chronic Kidney Disease Stage 3
- What is being tested?
- Dapagliflozin 10mg Tab, Balcinrenone 50mg Capsule and Balcinrenone 100mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jul 2023to 28 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic kidney disease, with eGFR ≥30 and ≤60 mL/min/1.73m2
- Serum/ plasma K+ levels ≥ 3.5 and < 5.0 mmol/L OR within normal laboratory ranges when these are provided, within 2 weeks prior to randomization
- Serum/plasma Na+ levels within normal reference values within 2 weeks prior to randomization
- If participants have type 2 diabetes mellitus, treatment with metformin, sulphonylureas, DPP4 inhibitors or any combinations of these agents with or without insulin would be accepted but is not mandatory. If used, stable dose of metformin, sulphonylureas, or DPP4 inhibitors or their combination as anti-diabetic therapy for the 12 weeks prior to randomization is required
- No changes in background treatment for at least 3 weeks prior to randomization
- Body mass index less than 40 kg/m2
- Negative pregnancy test (urine or serum) for female subjects of childbearing potential and willingness to use a highly effective birth control (see Appendix 4) if of childbearing potential.
- Willingness to participate and ability to provide signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Diagnosis of type 1 diabetes mellitus
- Uncontrolled type 2 diabetes mellitus with HbA1C > 10.5% in the most recent medical records
- Participants with type 2 diabetes mellitus treated with insulin if insulin dosing (intermediate, long-acting, premixed insulin, basal bolus insulin) was not stable in the 12 weeks prior to randomization as judged by the Investigator
- Patients with systolic blood pressure levels <100 mmHg at the time of enrolment
- Patients with congestive heart failure NYHA stage IV or hospitalized for decompensation of heart failure in the 3 months prior to screening
- History of any life-threatening cardiac arrhythmias, or uncontrolled ventricular rate in participants with atrial fibrillation or atrial flutter
Show all 27Show fewer
- Acute coronary syndrome and/or percutaneous cardiac interventions within 3 months prior to screening
- Unstable or rapidly progressing renal disease
- Chronic cystitis and recurrent genital or urinary tract infections
- Significant hepatic disease, including hepatitis and/or liver cirrhosis (Child-Pugh class A-C), or AST or ALT > 2 × ULN (upper limit of normal); or total bilirubin levels (TBL) > 2 × ULN; or serum albumin levels < 3.5 g/dL
- Medical conditions associated with development of hyperkalemia (Addison's disease)
- Stroke, transient ischemic attack, carotid surgery, or carotid angioplasty within 3 months prior to screening
- Hemoglobin levels below 8.5 g/dL or over 15 g/dL OR over the normal laboratory ranges, when these are provided
- Patients who have received an organ transplant at any time or bone marrow transplant in the previous 10 years
- HIV infection
- Active cancer, history of bladder cancer
- Patients who have had major surgery in the 3 months prior to screening
- Patients with muscular dystrophies
- Patients who have severe comorbid conditions likely to compromise survival or study participation
- Pregnant and breast-feeding women
- Medical treatment with either a mineralocorticoid receptor antagonist (MRA) or a sodium-glucose co-transporter-2 inhibitor (SGLT2i) within 3 months prior to screening
- Medical treatment with potassium binders
- Medical treatment with strong or moderate CYP3A4 inducers or inhibitors
- Prior serious hypersensitivity reaction to dapagliflozin (Forxiga®), balcinrenone or to any of their excipients
- Treatment with cytotoxic therapy, immunosuppressive therapy or other immunotherapy within 6 months prior to screening
- Unwillingness or other inability to cooperate
- For patients undergoing MRI scans, presence of implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants), iron-based tattoos, any other pieces of metal or devices that are not MR-safe anywhere in the body
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Assistance Publique-Hopitaux de Marseille (AP-HM)
Marseille, 13005
About this study
Official title: Natriuretic-ureothelic Adaptation of Body Fluid Homeostasis During SGLT-2 Inhibition and/or Mineralocorticoid Receptor Modulation in Patients With Chronic Kidney Disease. A 4-arm, Double-blind, Double-dummy, Parallel-group, Phase 2 Study to Investigate the Mechanistic Effects of Dapagliflozin, Dapagliflozin + Balcinrenone, Balcinrenone and Placebo on Body Solute and Water Homeostasis and Energy Metabolism in Male and Female Participants Over 50 Years of Age With Chronic Kidney Disease.
The purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in participants with stage 3 chronic kidney disease.
The study interventions will be administered orally, daily, in addition to current therapy, for a duration of 28 days. This will allow us to maximize our ability to detect a drug effect while minimizing the drop-out rate that accompanies longer studies.
Read more
In order to understand the different mechanistic effects of these interventions on energy metabolism, the study will be conducted at two study sites. The study design and treatment allocation, treatment duration as well as sample analysis for evaluation of the primary endpoint will be identical for all participants, at both sites. Therefore, urine and plasma samples for analysis of water and electrolyte handling will be collected from all study participants at both sites.
In addition to the primary endpoint, the main study site (Nuremberg) will conduct a metabolic study to investigate the early- and late-effects of the interventions, while the second site, Marseille, will conduct an imaging sub-study to assess changes at the tissue level before and after treatment.
Read the detailed description
The Nuremberg site will perform metabolomics analyses and evaluation of metabolic longevity switches in erythrocytes; participants will be randomly allocated to 1 of the 4 treatment arms, with n=25 participants per arm.
All participants in Nuremberg will undergo 3 study visits: at baseline, day 3 (to study the early effect of the intervention) and at day 28 (for the late metabolic effects). An additional safety study visit will take place at day 7+/-1. A follow-up visit will take place at day 28 +/- 7 after the last dose.
Study procedures: medical examination, height, weight, blood pressure (BP), heart rate (HR), 24h urine collection and analysis, venous blood sampling.
This site will prepare venous blood samples for metabolomic analysis and will perform the erythrocyte isolation protocol for the assessment of erythrocyte metabolism.
The Marseille site will conduct an imaging sub-study to evaluate tissue sodium and water content, and muscle energy metabolism before and after the study intervention; participants will be randomly allocated to 1 of the 4 treatment arms, with n=10 participants per arm.
All participants in Marseille will undergo 2 study visits: at baseline (before starting the intervention) and after 28 days of treatment. An additional safety study visit will take place at day 7+/-1. A follow-up visit will take place at day 28 +/- 7 after the last dose.
Study procedures: medical examination, height, weight, blood pressure, heart rate, 24h urine collection and analysis, venous blood sampling, MRI scans.
During each of the study visits at baseline and day 28 the participants will undergo 2 MRI scans: a 23Na MRI scan for the assessment of tissue sodium storage and water content at ultra-high field (7T MRI) and a spectroscopy scan for the assessment of muscle energy metabolism (phosphorus spectroscopy at 3T). The total duration of the scans at each study visit will be approximately 2h.
The Marseille recruitment site has been closed in October 2024 because of low recruitment rate. The recruitment will be completed in Nuremberg, and the number of patients has been increased to 25 patients per arm. Considering the very low drop-out rate in Nuremberg (2%) a total of 100 participants (25 per arm) will be randomized into the study. This number will suffice to achieve the necessary sample size of 23 patients for arm, and meet the necessary sample size for the primary endpoint according to the initial statistical power calculation : 23 per arm, accounting for a drop-out rate of 8%.
Enrolled means participants' or their legally acceptable representatives' agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol. A participant will be considered enrolled if the informed consent is not withdrawn prior to participating in any study activity after screening.
Participants in this study will be randomized into one of the 4 treatment arms:
- Balcinrenone 150 mg (n=30)
- Balcinrenone 150 mg + Dapagliflozin 10 mg (n=30)
- Dapagliflozin 10 mg (n=30)
- Placebo (n=30) For each group, 25 participants per group will complete the study (total n=100).
No dose modification, neither for dapagliflozin nor for balcinrenone, is planned during this study. To ensure a dose interval of about 24 hours, the medication should be taken every day in the morning. If a dose is missed by more than 12 hours, that dose should be skipped and the next dose should be taken as scheduled. No double doses should be taken.
Because of the short treatment duration in this study (28 days) no temporary discontinuation can take place, as this can affect the metabolic phenotype at day 3 and day 28. Therefore, if a participant needs to discontinue the study intervention, this participant will be withdrawn from the study and replaced.
Treatment duration will be 28 days, up to a maximum of 32 days to allow for scheduling flexibility. A follow-up visit will take place approximately one month (28 days +/-7 days) after the end of the intervention period. The screening visit may take place anytime within 4 weeks prior to Baseline visit. Therefore, the estimated total study duration for each participant, including screening and follow-up is 2 to 3 months.
- Conditions
- Chronic Renal Failure, Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis, Chronic Kidney Disease Stage 3, Electrolyte and Fluid Balance Conditions
- Being tested
- Dapagliflozin 10mg Tab, Balcinrenone 50mg Capsule, Balcinrenone 100mg Capsule, Dapagliflozin matching Placebo, Balcinrenone 50mg matching Placebo
- Keywords
- Chronic kidney disease, Water conservation, SGLT2 inhibitors, dapagliflozin, MR antagonists, balcinrenone, Amino acids, Energy metabolism
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Forxiga
see arms
Balcinrenone 50mg CapsuleDrug
see arms
Balcinrenone 100mg CapsuleDrug
see arms
Dapagliflozin matching PlaceboDrug
see arms
Balcinrenone 50mg matching PlaceboDrug
see arms
Balcinrenone 100mg matching PlaceboDrug
see arms
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | 1 tablet Dapagliflozin 10 mg + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo Receives: Drug: Dapagliflozin 10mg Tab; Drug: Balcinrenone 50mg matching Placebo; Drug: Balcinrenone 100mg matching Placebo |
| Balcinrenone | Experimental | 1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg + 1 tablet Dapagliflozin matching Placebo Receives: Drug: Balcinrenone 50mg Capsule; Drug: Balcinrenone 100mg Capsule; Drug: Dapagliflozin matching Placebo |
| Dapagliflozin + Balcinrenone | Experimental | 1 tablet Dapagliflozin 10mg + 1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg Receives: Drug: Dapagliflozin 10mg Tab; Drug: Balcinrenone 50mg Capsule; Drug: Balcinrenone 100mg Capsule |
| Placebo | Placebo comparator | 1 tablet Dapagliflozin matching Placebo + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo Receives: Drug: Dapagliflozin matching Placebo; Drug: Balcinrenone 50mg matching Placebo; Drug: Balcinrenone 100mg matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show that treatment with balcinrenone preserves the beneficial dapagliflozin-driven increase in 24h renal glucose excretion
Change from baseline in 24h urine glucose excretion at day 28
Measured: 28 days
Secondary outcomes (8)
To demonstrate that the dapagliflozin induced increase in urine solute concentration is not altered by balcinrenone
Change from baseline in urine osmolality at day 3 and day 28
Measured: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone reduces free-water clearance within 48h, and further urine concentration is observed after 4 weeks
Change from baseline in free water clearance at day 3 and day 28
Measured: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone, increases the contribution of glucose to osmoticdiuretic volume formation within 48h, and that this effect persists after 4 weeks
Change from baseline in urine glucose fraction at day 3 and day 28
Measured: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone, decreases the contribution of sodium and urea to osmotic-diuretic volume formation within 48h, and that this effect persists after 4 weeks
Change from baseline in urine sodium fraction at day 3 and day 28; Change from baseline in urine urea fraction at day 3 and day 28
Measured: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone, does not change the contribution of potassium to osmotic-diuretic volume formation within 48h, and that this effect persists after 4 weeks
Change from baseline in urine potassium fraction at day 3 and day 28
Measured: 28 days
To demonstrate that treatment with dapagliflozin with or without balcinrenone does not change body water content after 4 weeks
Change from baseline in muscle water content as measured at 7T MRI at day 28
Measured: 28 days
To demonstrate that patients treated with dapagliflozin alone or in combination with balcinrenone show increased plasma copeptin levels within 48h and/or after 4 weeks
Change from baseline in copeptin levels at day 3 and day 28
Measured: 28 days
To demonstrate that patients treated with dapagliflozin alone or in combination balcinrenone show increased plasma glucagon and reduced plasma insulin levels within 48h and/or after 4 weeks
Change from baseline in plasma insulin/glucagon ratio at day 3 and day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start13 Jul 2023
- Primary completion29 Dec 2025
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4-arm, double-blind, double-dummy, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Marton, Klinikum Nürnberg
- Investigators
- Adriana Marton, MD, Principal investigator, Klinikum Nuernberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884866
- Sponsor's protocol ID
- CT114-2022-01
- Other IDs
- 2022-002721-99
- Acronym
- DapaBalci-Leap
- Status last verified
- Apr 2026
- First submitted
- 9 May 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified individual participant data (IPD) collected during study visits will be shared, and only for participants who have provided informed consent for data sharing.
Publications
Marton A, Kaneko T, Kovalik JP, Yasui A, Nishiyama A, Kitada K, Titze J. Organ protection by SGLT2 inhibitors: role of metabolic energy and water conservation. Nat Rev Nephrol. 2021 Jan;17(1):65-77. doi: 10.1038/s41581-020-00350-x. Epub 2020 Oct 1.
PubMed 33005037Kovarik JJ, Morisawa N, Wild J, Marton A, Takase-Minegishi K, Minegishi S, Daub S, Sands JM, Klein JD, Bailey JL, Kovalik JP, Rauh M, Karbach S, Hilgers KF, Luft F, Nishiyama A, Nakano D, Kitada K, Titze J. Adaptive physiological water conservation explains hypertension and muscle catabolism in experimental chronic renal failure. Acta Physiol (Oxf). 2021 May;232(1):e13629. doi: 10.1111/apha.13629. Epub 2021 Mar 7.
PubMed 33590667Wild J, Jung R, Knopp T, Efentakis P, Benaki D, Grill A, Wegner J, Molitor M, Garlapati V, Rakova N, Marko L, Marton A, Mikros E, Munzel T, Kossmann S, Rauh M, Nakano D, Kitada K, Luft F, Waisman A, Wenzel P, Titze J, Karbach S. Aestivation motifs explain hypertension and muscle mass loss in mice with psoriatic skin barrier defect. Acta Physiol (Oxf). 2021 May;232(1):e13628. doi: 10.1111/apha.13628. Epub 2021 Feb 23.
PubMed 33590724Kitada K, Daub S, Zhang Y, Klein JD, Nakano D, Pedchenko T, Lantier L, LaRocque LM, Marton A, Neubert P, Schroder A, Rakova N, Jantsch J, Dikalova AE, Dikalov SI, Harrison DG, Muller DN, Nishiyama A, Rauh M, Harris RC, Luft FC, Wassermann DH, Sands JM, Titze J. High salt intake reprioritizes osmolyte and energy metabolism for body fluid conservation. J Clin Invest. 2017 May 1;127(5):1944-1959. doi: 10.1172/JCI88532. Epub 2017 Apr 17.
PubMed 28414295
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natriuretic-ureothelic Adaptation of Body Fluid Homeostasis During SGLT-2 Inhibition and/or Mineralocorticoid Receptor Modulation in Patients With Chronic Kidney Disease. A 4-arm, Double-blind, Double-dummy, Parallel-group, Phase 2 Study to Investigate the Mechanistic Effects of Dapagliflozin, Dapagliflozin + Balcinrenone, Balcinrenone and Placebo on Body Solute and Water Homeostasis and Energy Metabolism in Male and Female Participants Over 50 Years of Age With Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT05884866
- Acronym / sponsor ID
- DapaBalci-Leap / CT114-2022-01
- Conditions
- Chronic Renal Failure, Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis, Chronic Kidney Disease Stage 3, Electrolyte and Fluid Balance Conditions
- Keywords
- Chronic kidney disease, Water conservation, SGLT2 inhibitors, dapagliflozin, MR antagonists, balcinrenone, Amino acids, Energy metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Klinikum NürnbergUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in participants with stage 3 chronic kidney disease.
The study interventions will be administered orally, daily, in addition to current therapy, for a duration of 28 days. This will allow us to maximize our ability to detect a drug effect while minimizing the drop-out rate that accompanies longer studies.
In order to understand the different mechanistic effects of these interventions on energy metabolism, the study will be conducted at two study sites. The study design and treatment allocation, treatment duration as well as sample analysis for evaluation of the primary endpoint will be identical for all participants, at both sites. Therefore, urine and plasma samples for analysis of water and electrolyte handling will be collected from all study participants at both sites.
In addition to the primary endpoint, the main study site (Nuremberg) will conduct a metabolic study to investigate the early- and late-effects of the interventions, while the second site, Marseille, will conduct an imaging sub-study to assess changes at the tissue level before and after treatment.
Detailed description
The Nuremberg site will perform metabolomics analyses and evaluation of metabolic longevity switches in erythrocytes; participants will be randomly allocated to 1 of the 4 treatment arms, with n=25 participants per arm.
All participants in Nuremberg will undergo 3 study visits: at baseline, day 3 (to study the early effect of the intervention) and at day 28 (for the late metabolic effects). An additional safety study visit will take place at day 7+/-1. A follow-up visit will take place at day 28 +/- 7 after the last dose.
Study procedures: medical examination, height, weight, blood pressure (BP), heart rate (HR), 24h urine collection and analysis, venous blood sampling.
This site will prepare venous blood samples for metabolomic analysis and will perform the erythrocyte isolation protocol for the assessment of erythrocyte metabolism.
The Marseille site will conduct an imaging sub-study to evaluate tissue sodium and water content, and muscle energy metabolism before and after the study intervention; participants will be randomly allocated to 1 of the 4 treatment arms, with n=10 participants per arm.
All participants in Marseille will undergo 2 study visits: at baseline (before starting the intervention) and after 28 days of treatment. An additional safety study visit will take place at day 7+/-1. A follow-up visit will take place at day 28 +/- 7 after the last dose.
Study procedures: medical examination, height, weight, blood pressure, heart rate, 24h urine collection and analysis, venous blood sampling, MRI scans.
During each of the study visits at baseline and day 28 the participants will undergo 2 MRI scans: a 23Na MRI scan for the assessment of tissue sodium storage and water content at ultra-high field (7T MRI) and a spectroscopy scan for the assessment of muscle energy metabolism (phosphorus spectroscopy at 3T). The total duration of the scans at each study visit will be approximately 2h.
The Marseille recruitment site has been closed in October 2024 because of low recruitment rate. The recruitment will be completed in Nuremberg, and the number of patients has been increased to 25 patients per arm. Considering the very low drop-out rate in Nuremberg (2%) a total of 100 participants (25 per arm) will be randomized into the study. This number will suffice to achieve the necessary sample size of 23 patients for arm, and meet the necessary sample size for the primary endpoint according to the initial statistical power calculation : 23 per arm, accounting for a drop-out rate of 8%.
Enrolled means participants' or their legally acceptable representatives' agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol. A participant will be considered enrolled if the informed consent is not withdrawn prior to participating in any study activity after screening.
Participants in this study will be randomized into one of the 4 treatment arms:
- Balcinrenone 150 mg (n=30)
- Balcinrenone 150 mg + Dapagliflozin 10 mg (n=30)
- Dapagliflozin 10 mg (n=30)
- Placebo (n=30) For each group, 25 participants per group will complete the study (total n=100).
No dose modification, neither for dapagliflozin nor for balcinrenone, is planned during this study. To ensure a dose interval of about 24 hours, the medication should be taken every day in the morning. If a dose is missed by more than 12 hours, that dose should be skipped and the next dose should be taken as scheduled. No double doses should be taken.
Because of the short treatment duration in this study (28 days) no temporary discontinuation can take place, as this can affect the metabolic phenotype at day 3 and day 28. Therefore, if a participant needs to discontinue the study intervention, this participant will be withdrawn from the study and replaced.
Treatment duration will be 28 days, up to a maximum of 32 days to allow for scheduling flexibility. A follow-up visit will take place approximately one month (28 days +/-7 days) after the end of the intervention period. The screening visit may take place anytime within 4 weeks prior to Baseline visit. Therefore, the estimated total study duration for each participant, including screening and follow-up is 2 to 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4-arm, double-blind, double-dummy, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: Dapagliflozin 10mg Tab, Drug: Balcinrenone 50mg matching Placebo, Drug: Balcinrenone 100mg matching Placebo1 tablet Dapagliflozin 10 mg + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo |
| Balcinrenone | Experimental | Drug: Balcinrenone 50mg Capsule, Drug: Balcinrenone 100mg Capsule, Drug: Dapagliflozin matching Placebo1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg + 1 tablet Dapagliflozin matching Placebo |
| Dapagliflozin + Balcinrenone | Experimental | Drug: Dapagliflozin 10mg Tab, Drug: Balcinrenone 50mg Capsule, Drug: Balcinrenone 100mg Capsule1 tablet Dapagliflozin 10mg + 1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg |
| Placebo | Placebo comparator | Drug: Dapagliflozin matching Placebo, Drug: Balcinrenone 50mg matching Placebo, Drug: Balcinrenone 100mg matching Placebo1 tablet Dapagliflozin matching Placebo + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of chronic kidney disease, with eGFR ≥30 and ≤60 mL/min/1.73m2
- Serum/ plasma K+ levels ≥ 3.5 and < 5.0 mmol/L OR within normal laboratory ranges when these are provided, within 2 weeks prior to randomization
- Serum/plasma Na+ levels within normal reference values within 2 weeks prior to randomization
- If participants have type 2 diabetes mellitus, treatment with metformin, sulphonylureas, DPP4 inhibitors or any combinations of these agents with or without insulin would be accepted but is not mandatory. If used, stable dose of metformin, sulphonylureas, or DPP4 inhibitors or their combination as anti-diabetic therapy for the 12 weeks prior to randomization is required
- No changes in background treatment for at least 3 weeks prior to randomization
Key exclusion criteria (27 listed)
- Diagnosis of type 1 diabetes mellitus
- Uncontrolled type 2 diabetes mellitus with HbA1C > 10.5% in the most recent medical records
- Participants with type 2 diabetes mellitus treated with insulin if insulin dosing (intermediate, long-acting, premixed insulin, basal bolus insulin) was not stable in the 12 weeks prior to randomization as judged by the Investigator
- Patients with systolic blood pressure levels <100 mmHg at the time of enrolment
- Patients with congestive heart failure NYHA stage IV or hospitalized for decompensation of heart failure in the 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabAlso: Forxigasee arms | Drug | Dapagliflozin, Dapagliflozin + Balcinrenone |
| Balcinrenone 50mg Capsulesee arms | Drug | Balcinrenone, Dapagliflozin + Balcinrenone |
| Balcinrenone 100mg Capsulesee arms | Drug | Balcinrenone, Dapagliflozin + Balcinrenone |
| Dapagliflozin matching Placebosee arms | Drug | Balcinrenone, Placebo |
| Balcinrenone 50mg matching Placebosee arms | Drug | Dapagliflozin, Placebo |
| Balcinrenone 100mg matching Placebosee arms | Drug | Dapagliflozin, Placebo |
Primary outcome
To show that treatment with balcinrenone preserves the beneficial dapagliflozin-driven increase in 24h renal glucose excretion
Time frame: 28 days
Change from baseline in 24h urine glucose excretion at day 28
8 secondary outcomes
To demonstrate that the dapagliflozin induced increase in urine solute concentration is not altered by balcinrenone
Time frame: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone reduces free-water clearance within 48h, and further urine concentration is observed after 4 weeks
Time frame: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone, increases the contribution of glucose to osmoticdiuretic volume formation within 48h, and that this effect persists after 4 weeks
Time frame: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone, decreases the contribution of sodium and urea to osmotic-diuretic volume formation within 48h, and that this effect persists after 4 weeks
Time frame: 28 days
To demonstrate that treatment with dapagliflozin, with or without balcinrenone, does not change the contribution of potassium to osmotic-diuretic volume formation within 48h, and that this effect persists after 4 weeks
Time frame: 28 days
To demonstrate that treatment with dapagliflozin with or without balcinrenone does not change body water content after 4 weeks
Time frame: 28 days
To demonstrate that patients treated with dapagliflozin alone or in combination with balcinrenone show increased plasma copeptin levels within 48h and/or after 4 weeks
Time frame: 28 days
To demonstrate that patients treated with dapagliflozin alone or in combination balcinrenone show increased plasma glucagon and reduced plasma insulin levels within 48h and/or after 4 weeks
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 33005037Marton A, Kaneko T, Kovalik JP, Yasui A, Nishiyama A, Kitada K, Titze J. Organ protection by SGLT2 inhibitors: role of metabolic energy and water conservation. Nat Rev Nephrol. 2021 Jan;17(1):65-77. doi: 10.1038/s41581-020-00350-x. Epub 2020 Oct 1.
- Background: PubMed 33590667Kovarik JJ, Morisawa N, Wild J, Marton A, Takase-Minegishi K, Minegishi S, Daub S, Sands JM, Klein JD, Bailey JL, Kovalik JP, Rauh M, Karbach S, Hilgers KF, Luft F, Nishiyama A, Nakano D, Kitada K, Titze J. Adaptive physiological water conservation explains hypertension and muscle catabolism in experimental chronic renal failure. Acta Physiol (Oxf). 2021 May;232(1):e13629. doi: 10.1111/apha.13629. Epub 2021 Mar 7.
- Background: PubMed 33590724Wild J, Jung R, Knopp T, Efentakis P, Benaki D, Grill A, Wegner J, Molitor M, Garlapati V, Rakova N, Marko L, Marton A, Mikros E, Munzel T, Kossmann S, Rauh M, Nakano D, Kitada K, Luft F, Waisman A, Wenzel P, Titze J, Karbach S. Aestivation motifs explain hypertension and muscle mass loss in mice with psoriatic skin barrier defect. Acta Physiol (Oxf). 2021 May;232(1):e13628. doi: 10.1111/apha.13628. Epub 2021 Feb 23.
- Background: PubMed 28414295Kitada K, Daub S, Zhang Y, Klein JD, Nakano D, Pedchenko T, Lantier L, LaRocque LM, Marton A, Neubert P, Schroder A, Rakova N, Jantsch J, Dikalova AE, Dikalov SI, Harrison DG, Muller DN, Nishiyama A, Rauh M, Harris RC, Luft FC, Wassermann DH, Sands JM, Titze J. High salt intake reprioritizes osmolyte and energy metabolism for body fluid conservation. J Clin Invest. 2017 May 1;127(5):1944-1959. doi: 10.1172/JCI88532. Epub 2017 Apr 17.
- Individual participant dataSharing planned: Yes. Only de-identified individual participant data (IPD) collected during study visits will be shared, and only for participants who have provided informed consent for data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Marton, MD principal investigator
Klinikum Nuernberg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10mg Tab, Balcinrenone 50mg Capsule and Balcinrenone 100mg Capsule in people with Chronic Renal Failure and Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis, run by Klinikum Nürnberg at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To show that treatment with balcinrenone preserves the beneficial dapagliflozin-driven increase in 24h renal glucose excretion (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884866, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.