search
Back to results

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. (DapaBalci-Leap)

Primary Purpose

Chronic Renal Failure, Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin 10mg Tab
Balcinrenone 50mg Capsule
Balcinrenone 100mg Capsule
Dapagliflozin matching Placebo
Balcinrenone 50mg matching Placebo
Balcinrenone 100mg matching Placebo
Sponsored by
Klinikum Nürnberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Chronic kidney disease, Water conservation, SGLT2 inhibitors, dapagliflozin, MR antagonists, balcinrenone, Amino acids, Energy metabolism

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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. Exclusion Criteria: 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 7. 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 Patients who have received an organ or bone marrow transplant 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

Sites / Locations

  • Assistance Publique-Hopitaux de Marseille (AP-HM)
  • Klinikum NuernbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Balcinrenone

Dapagliflozin + Balcinrenone

Placebo

Arm Description

1 tablet Dapagliflozin 10 mg + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo

1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg + 1 tablet Dapagliflozin matching Placebo

1 tablet Dapagliflozin 10mg + 1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg

1 tablet Dapagliflozin matching Placebo + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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

Full Information

First Posted
May 9, 2023
Last Updated
May 23, 2023
Sponsor
Klinikum Nürnberg
search

1. Study Identification

Unique Protocol Identification Number
NCT05884866
Brief Title
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.
Acronym
DapaBalci-Leap
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum Nürnberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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=20 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. A maximum of 150 participants will be assigned to investigational intervention, to account for a 20% drop-out rate after initiation of the investigational intervention. A total of 120 participants (30 per arm) would be needed to complete the study. 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, 20 participants per group will complete the study in Nuremberg (total n=80) and 10 participants per group will complete the study in Marseille (total n=40). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis
Keywords
Chronic kidney disease, Water conservation, SGLT2 inhibitors, dapagliflozin, MR antagonists, balcinrenone, Amino acids, Energy metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
4-arm, double-blind, double-dummy, parallel-group
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blind, double-dummy
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Active Comparator
Arm Description
1 tablet Dapagliflozin 10 mg + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo
Arm Title
Balcinrenone
Arm Type
Experimental
Arm Description
1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg + 1 tablet Dapagliflozin matching Placebo
Arm Title
Dapagliflozin + Balcinrenone
Arm Type
Experimental
Arm Description
1 tablet Dapagliflozin 10mg + 1 capsule Balcinrenone 50mg + 1 capsule Balcinrenone 100 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet Dapagliflozin matching Placebo + 1 capsule Balcinrenone 50mg matching Placebo + 1 capsule Balcinrenone 100 mg matching Placebo
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg Tab
Other Intervention Name(s)
Forxiga
Intervention Description
see arms
Intervention Type
Drug
Intervention Name(s)
Balcinrenone 50mg Capsule
Intervention Description
see arms
Intervention Type
Drug
Intervention Name(s)
Balcinrenone 100mg Capsule
Intervention Description
see arms
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin matching Placebo
Intervention Description
see arms
Intervention Type
Drug
Intervention Name(s)
Balcinrenone 50mg matching Placebo
Intervention Description
see arms
Intervention Type
Drug
Intervention Name(s)
Balcinrenone 100mg matching Placebo
Intervention Description
see arms
Primary Outcome Measure Information:
Title
To show that treatment with balcinrenone preserves the beneficial dapagliflozin-driven increase in 24h renal glucose excretion
Description
Change from baseline in 24h urine glucose excretion at day 28
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To demonstrate that the dapagliflozin induced increase in urine solute concentration is not altered by balcinrenone
Description
Change from baseline in urine osmolality at day 3 and day 28
Time Frame
28 days
Title
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
Description
Change from baseline in free water clearance at day 3 and day 28
Time Frame
28 days
Title
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
Description
Change from baseline in urine glucose fraction at day 3 and day 28
Time Frame
28 days
Title
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
Description
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
Time Frame
28 days
Title
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
Description
Change from baseline in urine potassium fraction at day 3 and day 28
Time Frame
28 days
Title
To demonstrate that treatment with dapagliflozin with or without balcinrenone does not change body water content after 4 weeks
Description
Change from baseline in muscle water content as measured at 7T MRI at day 28
Time Frame
28 days
Title
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
Description
Change from baseline in copeptin levels at day 3 and day 28
Time Frame
28 days
Title
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
Description
Change from baseline in plasma insulin/glucagon ratio at day 3 and day 28
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
To demonstrate that treatment with dapagliflozin and/or balcinrenone for 4 weeks does not change tissue Na+ content as measured with MRI at 7T
Description
Change from baseline in tissue Na+ content at day 28
Time Frame
28 days
Title
To demonstrate that treatment with dapagliflozin with or without balcinrenone will increase muscle nitrogen transfer and induce pH changes during the rest-exercise-recovery period
Description
Change from baseline in pH levels levels at day 28 as quantified with 31P spectroscopy at 3T MRI
Time Frame
28 days
Title
To test the hypothesis that parallel to RAAS activation, patients treated with dapagliflozin show increased 24h urine cortisol excretion independent of parallel balcinrenone treatment
Description
Change from baseline in 24h urine cortisol levels at day 3 and day 28
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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 7. 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 Patients who have received an organ or bone marrow transplant 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrin Schoen
Phone
+499113987003
Email
kathrin.schoen@klinikum-nuernberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Marton, MD
Organizational Affiliation
Klinikum Nuernberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Marseille (AP-HM)
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joelle Rakotomavo
Phone
+33 491381338
Email
joelle.rakotomavo@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Stephane Burtey, MD
Facility Name
Klinikum Nuernberg
City
Nuremberg
State/Province
Bavaria
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Marton, MD
Email
adriana.marton@klinikum-nuernberg.de
First Name & Middle Initial & Last Name & Degree
Dominik Zaremba, MD
Phone
+4917681673788
Email
dominik.zaremba@klinikum-nuernberg.de
First Name & Middle Initial & Last Name & Degree
Adriana Marton, MD
First Name & Middle Initial & Last Name & Degree
Roland Veelken, Prof.
First Name & Middle Initial & Last Name & Degree
Dominik Zaremba, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33005037
Citation
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.
Results Reference
background
PubMed Identifier
33590667
Citation
Kovarik 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.
Results Reference
background
PubMed Identifier
33590724
Citation
Wild 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.
Results Reference
background
PubMed Identifier
28414295
Citation
Kitada 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.
Results Reference
background

Learn more about this trial

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.

We'll reach out to this number within 24 hrs