Patients With Type 2 DiabetesPhase 4RAiSiNNCT06727409
Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i as Triple Therapy With Type 2 Diabetes and Chronic Kidney Disease
A Phase 4 study testing Finerenone in people with Patients With Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Type 2 Diabetes
- What is being tested?
- Finerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Dec 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or above
- Diagnosis of type 2 diabetes at least 6 months
- CKD (eGFR by CKD-EPI 25-90 ml/min/1.73m2 with uACR 30 to <300 mg/g) and/or those with severely elevated albuminuria (uACR 30-5000 mg/g) and eGFR > 60 ml/min/1.73m2.
- Patients should have a serum potassium <4.8 mmol/l at screening
- On SGLT2i (dapagliflozin or empaglifozin) at screening at stable doses for at least 4 weeks.
- On ACEi or ARB at maximum tolerated dose per manufacturer's label that did not cause unacceptable side effects
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
Who cannot join
- Type 1 diabetes
- Allergy, contraindications or intolerance to ACEi/ARB
- Contraindications or intolerance to mineralocorticoid receptor antagonists
- Allergy, contraindications to SGLT2is
- Currently pregnant or planning pregnancy
- HbA1c >9% at enrolment
Show all 15Show fewer
- Uncontrolled hypertension SBP > 160mmHg or hypotension <90 mmHg at enrolment
- Concomitant therapy with eplenerone, spironolactone that cannot be discontinued.
- History of stroke or worsening heart failure in the past 6 months prior to screening
- Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
- Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period
- On concomitant strong CYP3A4 inhibitors that cannot be discontinued
- Adrenal insufficiency
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
3M, Diabetes and Endocrine Research Center
Hong Kong
Elaine Chow, MD, +852 35051641, e.chow@cuhk.edu.hk
Shun Ling KONG, MN, +852 35052648, slkong@cuhk.edu.hk
About this study
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
- Conditions
- Patients With Type 2 Diabetes
- Being tested
- Finerenone
- Keywords
- Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Finerenone 10mg or 20 mg as tolerated on top of maximal tolerated RASi and stable SGLT2i therapy
| Study group | Role | What they receive |
|---|---|---|
| Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy | Experimental | pre and post Finerenone treatment evaluation Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine albumin creatinine ratio (uACR)
urine ACR between baseline and end of study (26 weeks)
Measured: 26 weeks
Secondary outcomes (5)
Change in estimated glomerular filtration rate (eGFR)
eGFR calculated from plasma creatinine from baseline to end of study in ml/min/1.73m2
Measured: 26 weeks
Change in potassium
Change in plasma potassium (mmol/l) from baseline to end of study
Measured: 26 weeks
Change in blood pressure
Change in systolic and diastolic blood pressure (mmHg) from baseline to end of study
Measured: 26 weeks
Change in heath related quality of life
change in HRQoL from baseline to end of study using EQ5D
Measured: 26 weeks
Change in body weight
Change in body weight (kg) from baseline to end of study
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start12 Dec 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- in parallel fashion to optimise tolerated doses of Finerenone
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Chow, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727409
- Sponsor's protocol ID
- RAiSiN
- Other IDs
- CREC number: 2023.615-T
- Acronym
- RAiSiN
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i as Triple Therapy With Type 2 Diabetes and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06727409
- Acronym / sponsor ID
- RAiSiN / RAiSiN
- Conditions
- Patients With Type 2 Diabetes
- Keywords
- Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 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.
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- in parallel fashion to optimise tolerated doses of Finerenone
| Arm | Type | Receives |
|---|---|---|
| Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy | Experimental | Drug: Finerenonepre and post Finerenone treatment evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or above
- Diagnosis of type 2 diabetes at least 6 months
- CKD (eGFR by CKD-EPI 25-90 ml/min/1.73m2 with uACR 30 to <300 mg/g) and/or those with severely elevated albuminuria (uACR 30-5000 mg/g) and eGFR > 60 ml/min/1.73m2.
- Patients should have a serum potassium <4.8 mmol/l at screening
- On SGLT2i (dapagliflozin or empaglifozin) at screening at stable doses for at least 4 weeks.
Key exclusion criteria (15 listed)
- Type 1 diabetes
- Allergy, contraindications or intolerance to ACEi/ARB
- Contraindications or intolerance to mineralocorticoid receptor antagonists
- Allergy, contraindications to SGLT2is
- Currently pregnant or planning pregnancy
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 |
|---|---|---|
| FinerenoneFinerenone 10mg or 20 mg as tolerated on top of maximal tolerated RASi and stable SGLT2i therapy | Drug | Finerenone on top of maximal tolerated RASi and stable SGLT2i therapy |
Primary outcome
Change in urine albumin creatinine ratio (uACR)
Time frame: 26 weeks
urine ACR between baseline and end of study (26 weeks)
5 secondary outcomes
Change in estimated glomerular filtration rate (eGFR)
Time frame: 26 weeks
Change in potassium
Time frame: 26 weeks
Change in blood pressure
Time frame: 26 weeks
Change in heath related quality of life
Time frame: 26 weeks
Change in body weight
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Finerenone in people with Patients With Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Chow (+852 35051641, e.chow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine albumin creatinine ratio (uACR) (time frame: 26 weeks). 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 5 Mar 2025.