Alport SyndromePhase 4COMBINE-ALPORTNCT06499948
Albuminuria Lowering Effect of Dapagliflozin, Spironolactone and Their Combination in Adult Patients With Alport Syndrome (COMBINE-ALPORT)
A Phase 4 study testing Treatment with Spironolactone followed by Dapagliflozin followed by their combination and Treatment with Dapagliflozin followed by Spironolactone followed by their combination in people with Alport Syndrome and Thin Basement Membrane Disease, run by Stefan Lujinschi at 1 site in Romania.
Trial summary
Alport syndrome (AS) is one of the most common monogenic kidney disorders, oftentimes leading to end-stage kidney disease (ESKD). As AS is caused by variants involving type IV collagen genes (COL4), there is no specific treatment aimed at stopping the disease progression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alport Syndrome, Thin Basement Membrane Disease, Alport Nephropathy
- What is being tested?
- Treatment with Spironolactone followed by Dapagliflozin followed by their combination and Treatment with Dapagliflozin followed by Spironolactone followed by their combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteRomania
- Study dates
- 26 Feb 2024to 30 Apr 2026
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Genetically proven Alport syndrome (AS) - defined as following:
- gt;Men having hemizygous pathogenic/likely pathogenic variants involving COL4A5 gene - classified as X-linked AS involving men
- gt;Women having heterozygous pathogenic/likely pathogenic variants involving COL4A5 gene - classified as X-linked AS involving women
- gt;Both men and women with heterozygous pathogenic/likely pathogenic variants involving COL4A3 or COL4A4 genes - classified as autosomal dominant AS
- gt;Both men and women with homozygous pathogenic/likely pathogenic variants involving COL4A3 or COL4A4 genes - classified as autosomal recessive AS
- gt;Patients having variants of uncertain significance will be included if the fulfill at least 2 of the following criteria: (1) clinical features suggestive of AS, (2) positive family history suggestive of AS (i.e., at least one grade I relative having the same variant and presenting clinical features suggestive of AS) and (3) kidney biopsy showing the characteristic lesion of AS (i.e., structural defect of the glomerular basement membrane, "basket-wave" appearance of the basement membrane, lamination of the basement membrane) or for thin basement membrane disease (i.e., diffusely thin basement membrane)
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- Age between 18 and 70 years-old at the time of enrolment
- Baseline estimated glomerular filtration rate (eGFR) over 10ml/min/1.73m2 at the time of enrolment
- Stable kidney function: variation of eGFR under 25% from baseline in the last 6 weeks before randomization
- 24-hours urine albumin-to-creatinine ratio greater than 30 mg/g after adjusting the dose of renin-angiotensin-system inhibitor
- Stable renin-angiotensin-system inhibitor dose for at least 2 weeks before randomization
Who cannot join
- The need for kidney replacement therapy (i.e., hemodialysis, peritoneal dialysis, and kidney transplant) for more than 4 weeks in the last 12 months before enrollment
- Treatment with Spironolactone or Dapagliflozin for more than 14 days in the last 28 days prior to enrollment
- History of prior serious adverse event due to Spironolactone or Dapagliflozin
- Active neoplasia
- Autosomal dominant or recessive polycystic kidney disease
- Type I diabetes
Show all 11Show fewer
- Patients with type II diabetes and diabetic nephropathy
- Diagnosis of another concomitant distinct glomerulopathy (with the exception of concomitant IgA nephropathy on kidney biopsy)
- Pregnancy and breastfeeding
- History of solid organ transplant
- Immunosuppressive treatment in the last 12 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Unicentric, Randomized, Open-label, Cross-over Clinical Trial to Assess the Effect of Dapagliflozin, Spironolactone and Their Combination, When Added to Renin-Angiotensin System Blockade, On Lowering Urine Albumin-to-Creatinine Ratio in Adult Patients With Alport Syndrome
Alport syndrome (AS) is one of the most common monogenic kidney disorders, oftentimes leading to end-stage kidney disease (ESKD). As AS is caused by variants involving type IV collagen genes (COL4), there is no specific treatment aimed at stopping the disease progression. Large studies have validated the use of renin-angiotensin-system inhibitors (RASis) in AS, as these drugs can slow the progression to chronic kidney disease (CKD). These studies included mainly pediatric patients with X-linked AS (XLAS). There is a lack of data regarding the therapeutic approach in patients having autosomal dominant AS (ADAS).
Recent data from murine studies suggest that the combined therapy using a sodium-glucose-cotransporter 2 inhibitor (SGLT2i) and a mineralocorticoid receptor blocker (MRB) can reduce proteinuria in COL4A3 knock-out mice. The albuminuria lowering effect of this combination was demonstrated in other non-diabetic nephropathies. Used in monotherapy, both drugs have showed protective and antifibrotic effects in murine models of AS.
Read more
The COMBINE-ALPORT trial aims to evaluate the albuminuria lowering effect of Dapagliflozin, Spironolactone and their combination in adult patients with genetically proven AS when added to maximum tolerated RASi dose. As proteinuria is the primary driver of CKD progression, and the change in albuminuria is widely used as a surrogate endpoint for kidney disease progression, lowering albuminuria will delay the onset of ESKD in patients with AS.
The main hypothesis of COMBINE-ALPORT trial is that the association of Dapagliflozin and Spironolactone will significantly reduce albuminuria in adult patient with AS.
The patients will be randomized to receive either Spironolactone or Dapagliflozin on top of standard therapy (maximum RASi dose) in a cross-over trial design (4 weeks of treatment followed by 4 weeks of wash-out). Finally, the whole cohort will receive both Spironolactone and Dapagliflozin for another 4 weeks.
The patients will visit the clinic every 4 weeks for checkups and tests.
The primary outcome is the effect on albuminuria by each treatment regimen (Spironolactone, Dapagliflozin or their combination).
- Being tested
- Treatment with Spironolactone followed by Dapagliflozin followed by their combination, Treatment with Dapagliflozin followed by Spironolactone followed by their combination
- Keywords
- Alport syndrome, Type IV collagen, Albuminuria, Chronic kidney disease, Monogenic kidney disorders, Glomerulopathy
- Medical subject headings
- Nephritis, Hereditary, Hematuria, Benign Familial, Albuminuria, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Spironolactone followed by Dapagliflozin followed by their combinationDrug
Also called Treatment succession no. 1, Spironolactone-Dapagliflozin-Combination, SDC succession, Spironolactone first
After titrating the renin-angiotensin-system inhibitor dose, patients will receive 25 mg of Spironolactone once daily for 4 weeks. Spironolactone will be stopped after 4 weeks. The first treatment period will be followed by 4 weeks of wash-out. After the first wash-out period, treatment with Dapagliflozin will be started. Patients will receive 10 mg of Dapagliflozin once daily for 4 weeks. Dapagliflozin will be stopped after 4 weeks. The second treatment period will be followed by 4 weeks of wash-out. After the second wash-out period, treatment with both Spironolactone 25 mg and Dapagliflozin will be started. Patients will receive 25 mg of Spironolactone once daily in combination with 10 mg of Dapagliflozin daily for a duration of 4 weeks. Spironolactone and Dapagliflozin will be stopped after 4 weeks. The third treatment period will be followed by 4 weeks of wash-out, after which the study will be finalized.
Treatment with Dapagliflozin followed by Spironolactone followed by their combinationDrug
Also called Treatment succession no. 2, Dapagliflozin-Spironolactone-Combination, DSC succession, Dapagliflozin first
After titrating the renin-angiotensin-system inhibitor dose, patients will receive 10 mg of Dapagliflozin once daily for 4 weeks. Dapagliflozin will be stopped after 4 weeks. The first treatment period will be followed by 4 weeks of wash-out. After the first wash-out period, treatment with Spironolactone will be started. Patients will receive 25 mg of Spironolactone once daily for 4 weeks. Spironolactone will be stopped after 4 weeks. The second treatment period will be followed by 4 weeks of wash-out. After the second wash-out period, treatment with both Spironolactone and Dapagliflozin will be started. Patients will receive 25 mg of Spironolactone once daily in combination with 10 mg of Dapagliflozin daily for a duration of 4 weeks. Spironolactone and Dapagliflozin will be stopped after 4 weeks. The third treatment period will be followed by 4 weeks of wash-out, after which the study will be finalized.
| Study group | Role | What they receive |
|---|---|---|
| Succession no.1: Spironolactone followed by Dapagliflozin followed by the combined therapy arm | Experimental | The patients will be randomized to receive either Spironolactone or Dapagliflozin on top of standard therapy (stable doses of renin-angiotensin-system inhibitors) in a crossover trial design (4 weeks of treatment followed by 4 weeks of wash-out). Finally, the whole cohort will receive both Spironolactone and Dapagliflozin for another 4 weeks.
Treatment succession no.1 description: (1)1st treatment period - patients will receive Spironolactone 25 mg od on top of standard for 4 weeks; (2) 1st washout-period - treatment with Spironolactone will be stopped for 4 weeks; (3) 2nd treatment period - patients will receive Dapagliflozin 10 mg od for 4 weeks; (4) 2nd washout-period - treatment with Dapagliflozin will be stopped for 4 weeks; (5) 3rd treatment period - patients will receive Spironolactone 25 mg od plus Dapagliflozin 10 mg od for 4 weeks; (6) 3rd washout-period - treatment with Spironolactone and Dapagliflozin will be stopped for 4 weeks. Receives: Drug: Treatment with Spironolactone followed by Dapagliflozin followed by their combination |
| Succession no.2: Dapagliflozin followed by Spironolactone followed by the combined therapy arm | Experimental | The patients will be randomized to receive either Spironolactone or Dapagliflozin on top of standard therapy (stable doses of renin-angiotensin-system inhibitors) in a crossover trial design (4 weeks of treatment followed by 4 weeks of wash-out). Finally, the whole cohort will receive both Spironolactone and Dapagliflozin for another 4 weeks.
Treatment succession no.2 description: (1) 1st treatment period - patients will receive Dapagliflozin 10 mg od on top of standard for 4 weeks; (2) 1st washout-period - treatment with Dapagliflozin will be stopped for 4 weeks; (3) 2nd treatment period - patients will receive Spironolactone 25 mg od for 4 weeks; (4) 2nd washout-period - treatment with Spironolactone will be stopped for 4 weeks; (5) 3rd treatment period - patients will receive Spironolactone 25 mg od plus Dapagliflozin 10 mg od for 4 weeks; (6) 3rd washout-period - treatment with Spironolactone and Dapagliflozin will be stopped for 4 weeks. Receives: Drug: Treatment with Dapagliflozin followed by Spironolactone followed by their combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hours urine albumin-to-creatinine ratio (UACR) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Measured: 24-hours UACR will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment
Secondary outcomes (4)
Change in estimated glomerular filtration ratio (eGFR) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Measured: eGFR will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment
Change in serum potassium compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Measured: Serum K will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment
The occurrence of adverse events, including serious adverse events
Measured: During and after each period of treatment, up to 24 weeks after randomization (30 weeks after assessing eligibility)
Change in urinary electrolytes excretion (sodium and potassium) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Measured: Urinary sodium and potassium will me measured each 4 weeks up to 24 weeks after randomization: before and after each period of treatment and wash-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start26 Feb 2024
- Primary completion21 Nov 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alport SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Timeline: * First visit - screening and eligibility: assessing eligibility and adjusting the renin-angiotensin-system inhibitor dose (2 weeks); * Second visit - stable dose of renin-angiotensin-system inhibitor (4 weeks); * Third visit - randomization: patients are randomized to receive either Spironolactone 25 mg od or Dapagliflozin 10 mg od (first treatment period: 4 weeks); * Fourth visit - first wash-out: the intervention is stopped (4 weeks); * Fifth visit - second treatment period: switching the treatment between the two groups (second treatment period: 4 weeks); * Sixth visit - second wash-out: the intervention is stopped (4 weeks); * Seventh visit - third treatment period: the whole cohort will receive the combined therapy consisting in Dapagliflozin 10 mg od and Spironolactone 25 mg od (4 weeks); * Eighth visit - third wash-out: the intervention is stopped (4 weeks); * Ninth visit - end of study: after the third wash-out period is finished.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Lujinschi
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, Institutul Clinic Fundeni
- Responsible party
- Sponsor-investigator, Stefan Lujinschi, Institutul Clinic Fundeni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499948
- Sponsor's protocol ID
- 66035
- Acronym
- COMBINE-ALPORT
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unicentric, Randomized, Open-label, Cross-over Clinical Trial to Assess the Effect of Dapagliflozin, Spironolactone and Their Combination, When Added to Renin-Angiotensin System Blockade, On Lowering Urine Albumin-to-Creatinine Ratio in Adult Patients With Alport Syndrome
- ClinicalTrials.gov ID
- NCT06499948
- Acronym / sponsor ID
- COMBINE-ALPORT / 66035
- Keywords
- Alport syndrome, Type IV collagen, Albuminuria, Chronic kidney disease, Monogenic kidney disorders, Glomerulopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stefan LujinschiUniversity, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, Institutul Clinic Fundeni
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 15 Jul 2024 (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.
Alport syndrome (AS) is one of the most common monogenic kidney disorders, oftentimes leading to end-stage kidney disease (ESKD). As AS is caused by variants involving type IV collagen genes (COL4), there is no specific treatment aimed at stopping the disease progression. Large studies have validated the use of renin-angiotensin-system inhibitors (RASis) in AS, as these drugs can slow the progression to chronic kidney disease (CKD). These studies included mainly pediatric patients with X-linked AS (XLAS). There is a lack of data regarding the therapeutic approach in patients having autosomal dominant AS (ADAS).
Recent data from murine studies suggest that the combined therapy using a sodium-glucose-cotransporter 2 inhibitor (SGLT2i) and a mineralocorticoid receptor blocker (MRB) can reduce proteinuria in COL4A3 knock-out mice. The albuminuria lowering effect of this combination was demonstrated in other non-diabetic nephropathies. Used in monotherapy, both drugs have showed protective and antifibrotic effects in murine models of AS.
The COMBINE-ALPORT trial aims to evaluate the albuminuria lowering effect of Dapagliflozin, Spironolactone and their combination in adult patients with genetically proven AS when added to maximum tolerated RASi dose. As proteinuria is the primary driver of CKD progression, and the change in albuminuria is widely used as a surrogate endpoint for kidney disease progression, lowering albuminuria will delay the onset of ESKD in patients with AS.
The main hypothesis of COMBINE-ALPORT trial is that the association of Dapagliflozin and Spironolactone will significantly reduce albuminuria in adult patient with AS.
The patients will be randomized to receive either Spironolactone or Dapagliflozin on top of standard therapy (maximum RASi dose) in a cross-over trial design (4 weeks of treatment followed by 4 weeks of wash-out). Finally, the whole cohort will receive both Spironolactone and Dapagliflozin for another 4 weeks.
The patients will visit the clinic every 4 weeks for checkups and tests.
The primary outcome is the effect on albuminuria by each treatment regimen (Spironolactone, Dapagliflozin or their combination).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Timeline: * First visit - screening and eligibility: assessing eligibility and adjusting the renin-angiotensin-system inhibitor dose (2 weeks); * Second visit - stable dose of renin-angiotensin-system inhibitor (4 weeks); * Third visit - randomization: patients are randomized to receive either Spironolactone 25 mg od or Dapagliflozin 10 mg od (first treatment period: 4 weeks); * Fourth visit - first wash-out: the intervention is stopped (4 weeks); * Fifth visit - second treatment period: switching the treatment between the two groups (second treatment period: 4 weeks); * Sixth visit - second wash-out: the intervention is stopped (4 weeks); * Seventh visit - third treatment period: the whole cohort will receive the combined therapy consisting in Dapagliflozin 10 mg od and Spironolactone 25 mg od (4 weeks); * Eighth visit - third wash-out: the intervention is stopped (4 weeks); * Ninth visit - end of study: after the third wash-out period is finished.
| Arm | Type | Receives |
|---|---|---|
| Succession no.1: Spironolactone followed by Dapagliflozin followed by the combined therapy arm | Experimental | Drug: Treatment with Spironolactone followed by Dapagliflozin followed by their combinationThe patients will be randomized to receive either Spironolactone or Dapagliflozin on top of standard therapy (stable doses of renin-angiotensin-system inhibitors) in a crossover trial design (4 weeks of treatment followed by 4 weeks of wash-out). Finally, the whole cohort will receive both Spironolactone and Dapagliflozin for another 4 weeks. Treatment succession no.1 description: (1)1st treatment period - patients will receive Spironolactone 25 mg od on top of standard for 4 weeks; (2) 1st washout-period - treatment with Spironolactone will be stopped for 4 weeks; (3) 2nd treatment period - patients will receive Dapagliflozin 10 mg od for 4 weeks; (4) 2nd washout-period - treatment with Dapagliflozin will be stopped for 4 weeks; (5) 3rd treatment period - patients will receive Spironolactone 25 mg od plus Dapagliflozin 10 mg od for 4 weeks; (6) 3rd washout-period - treatment with Spironolactone and Dapagliflozin will be stopped for 4 weeks. |
| Succession no.2: Dapagliflozin followed by Spironolactone followed by the combined therapy arm | Experimental | Drug: Treatment with Dapagliflozin followed by Spironolactone followed by their combinationThe patients will be randomized to receive either Spironolactone or Dapagliflozin on top of standard therapy (stable doses of renin-angiotensin-system inhibitors) in a crossover trial design (4 weeks of treatment followed by 4 weeks of wash-out). Finally, the whole cohort will receive both Spironolactone and Dapagliflozin for another 4 weeks. Treatment succession no.2 description: (1) 1st treatment period - patients will receive Dapagliflozin 10 mg od on top of standard for 4 weeks; (2) 1st washout-period - treatment with Dapagliflozin will be stopped for 4 weeks; (3) 2nd treatment period - patients will receive Spironolactone 25 mg od for 4 weeks; (4) 2nd washout-period - treatment with Spironolactone will be stopped for 4 weeks; (5) 3rd treatment period - patients will receive Spironolactone 25 mg od plus Dapagliflozin 10 mg od for 4 weeks; (6) 3rd washout-period - treatment with Spironolactone and Dapagliflozin will be stopped for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Genetically proven Alport syndrome (AS) - defined as following:
- Age between 18 and 70 years-old at the time of enrolment
- Baseline estimated glomerular filtration rate (eGFR) over 10ml/min/1.73m2 at the time of enrolment
- Stable kidney function: variation of eGFR under 25% from baseline in the last 6 weeks before randomization
- 24-hours urine albumin-to-creatinine ratio greater than 30 mg/g after adjusting the dose of renin-angiotensin-system inhibitor
Key exclusion criteria (11 listed)
- The need for kidney replacement therapy (i.e., hemodialysis, peritoneal dialysis, and kidney transplant) for more than 4 weeks in the last 12 months before enrollment
- Treatment with Spironolactone or Dapagliflozin for more than 14 days in the last 28 days prior to enrollment
- History of prior serious adverse event due to Spironolactone or Dapagliflozin
- Active neoplasia
- Autosomal dominant or recessive polycystic kidney disease
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 |
|---|---|---|
| Treatment with Spironolactone followed by Dapagliflozin followed by their combinationAlso: Treatment succession no. 1, Spironolactone-Dapagliflozin-Combination, SDC succession, Spironolactone firstAfter titrating the renin-angiotensin-system inhibitor dose, patients will receive 25 mg of Spironolactone once daily for 4 weeks. Spironolactone will be stopped after 4 weeks. The first treatment period will be followed by 4 weeks of wash-out. After the first wash-out period, treatment with Dapagliflozin will be started. Patients will receive 10 mg of Dapagliflozin once daily for 4 weeks. Dapagliflozin will be stopped after 4 weeks. The second treatment period will be followed by 4 weeks of wash-out. After the second wash-out period, treatment with both Spironolactone 25 mg and Dapagliflozin will be started. Patients will receive 25 mg of Spironolactone once daily in combination with 10 mg of Dapagliflozin daily for a duration of 4 weeks. Spironolactone and Dapagliflozin will be stopped after 4 weeks. The third treatment period will be followed by 4 weeks of wash-out, after which the study will be finalized. | Drug | Succession no.1: Spironolactone followed by Dapagliflozin followed by the combined therapy arm |
| Treatment with Dapagliflozin followed by Spironolactone followed by their combinationAlso: Treatment succession no. 2, Dapagliflozin-Spironolactone-Combination, DSC succession, Dapagliflozin firstAfter titrating the renin-angiotensin-system inhibitor dose, patients will receive 10 mg of Dapagliflozin once daily for 4 weeks. Dapagliflozin will be stopped after 4 weeks. The first treatment period will be followed by 4 weeks of wash-out. After the first wash-out period, treatment with Spironolactone will be started. Patients will receive 25 mg of Spironolactone once daily for 4 weeks. Spironolactone will be stopped after 4 weeks. The second treatment period will be followed by 4 weeks of wash-out. After the second wash-out period, treatment with both Spironolactone and Dapagliflozin will be started. Patients will receive 25 mg of Spironolactone once daily in combination with 10 mg of Dapagliflozin daily for a duration of 4 weeks. Spironolactone and Dapagliflozin will be stopped after 4 weeks. The third treatment period will be followed by 4 weeks of wash-out, after which the study will be finalized. | Drug | Succession no.2: Dapagliflozin followed by Spironolactone followed by the combined therapy arm |
Primary outcome
Change in 24-hours urine albumin-to-creatinine ratio (UACR) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Time frame: 24-hours UACR will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment
4 secondary outcomes
Change in estimated glomerular filtration ratio (eGFR) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Time frame: eGFR will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment
Change in serum potassium compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Time frame: Serum K will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment
The occurrence of adverse events, including serious adverse events
Time frame: During and after each period of treatment, up to 24 weeks after randomization (30 weeks after assessing eligibility)
Change in urinary electrolytes excretion (sodium and potassium) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination
Time frame: Urinary sodium and potassium will me measured each 4 weeks up to 24 weeks after randomization: before and after each period of treatment and wash-out
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment with Spironolactone followed by Dapagliflozin followed by their combination and Treatment with Dapagliflozin followed by Spironolactone followed by their combination in people with Alport Syndrome and Thin Basement Membrane Disease, run by Stefan Lujinschi at 1 site in Romania.
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 11 inclusion and 11 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in 24-hours urine albumin-to-creatinine ratio (UACR) compared to baseline after treatment with Dapagliflozin, Spironolactone and with their combination (time frame: 24-hours UACR will be measured at 0, 2, 6, 10, 14, 18, 22, 26 and 30 weeks after eligibility assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.