A comparison of two drugs for treating patients with Chronic Kidney Disease and protein in the urine

Sodium glucose cotransporter 2 inhibitors or Mineralocorticoid receptor antagonists for the treatment of Albuminuric Chronic Kidney Disease - A randomized controlled trial - SMACKD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000740-29-DK

Enrollment

Registered

2022-03-04

Start date

2022-04-12

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease with albuminuria MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10001580 Term: Albuminuria System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Finerenone Pharmaceutical Form: Tablet INN or Proposed INN: Finerenone CAS Number: 1050477-31-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-80 2. eGFR 25-45 3. Urine albumine creatinine ratio 150-2000 mg/g 4. Current treatment with maximal RAAS-blockade (ACE-I/ARB) or maximal tolerated dose as judged by the investigator 5. Current stable treatment with ACE-I/ARB (i.e. dose unchanged for the past 4 weeks) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Diabetes 2. ADPKD 3. Active vasculitis (current or planned treatment) with renal involvement 4. Systolic BP > 160mmHg or diastolic BP > 100mmHg 5. P-potassium >4.5mmol/L

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this trial is to investigate and compare the effect of Finerenone and Dapagliflozine on albuminuria, both separately and in combination, added to treatment with ACE-I/ARB in patients with non-diabetic chronic kidney disease and albuminuria.;Secondary Objective: The study will further investigate the safety and tolerability of separate and combined treatment including the effect on renal blood flow, oxygenation and glomerular filtration rate, P-potassium, blood pressure and the possible mechanism behind a renoprotective effect.;Primary end point(s): The change in albuminuria from baseline to after combined treatment with Dapagliflozine og Finerenone;Timepoint(s) of evaluation of this end point: Baseline and after 8 weeks	—

Measure

Time frame

Main Objective: The objective of this trial is to investigate and compare the effect of Finerenone and Dapagliflozine on albuminuria, both separately and in combination, added to treatment with ACE-I/ARB in patients with non-diabetic chronic kidney disease and albuminuria.;Secondary Objective: The study will further investigate the safety and tolerability of separate and combined treatment including the effect on renal blood flow, oxygenation and glomerular filtration rate, P-potassium, blood pressure and the possible mechanism behind a renoprotective effect.;Primary end point(s): The change in albuminuria from baseline to after combined treatment with Dapagliflozine og Finerenone;Timepoint(s) of evaluation of this end point: Baseline and after 8 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Change in GFR measured using 99mTecnetium-DTPA 2. Change in renal bloodflow and oxygenation measured using BOLD-MR R2* 3. P-potassium 4. Change in blood pressure measured at home and using BpTRU 5. Changes in above measured at 4 weeks (Dapagliflozine or Finerenone) vs. baseline and 8 weeks (combined treatment) vs. 4 weeks (single drug);Timepoint(s) of evaluation of this end point: Baseline, 4 and 8 weeks	—

Measure

Time frame

Secondary end point(s): 1. Change in GFR measured using 99mTecnetium-DTPA 2. Change in renal bloodflow and oxygenation measured using BOLD-MR R2* 3. P-potassium 4. Change in blood pressure measured at home and using BpTRU 5. Changes in above measured at 4 weeks (Dapagliflozine or Finerenone) vs. baseline and 8 weeks (combined treatment) vs. 4 weeks (single drug);Timepoint(s) of evaluation of this end point: Baseline, 4 and 8 weeks

—

Countries

Denmark

Contacts

Public ContactFrederik Husum Mårup

Department of Renal Medicine, Aarhus University Hospital

fremaa@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026