A Phase 4 interventional study of Finerenone and Semaglutide in Chronic Kidney Disease and Type 2 Diabetes, sponsored by Baylor Research Institute. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Baylor Research Institute · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease.
The main questions it aims to answer are:
Researchers will compare this approach to usual care, where medicines are started one at a time over several months.
Participants will:
Be assigned by chance to either this approach or usual care Start up to four approved kidney medicines over about 8 weeks (rapid treatment approach) or follow standard care Have regular clinic visits and lab tests to check kidney function and potassium levels Be followed for about 6 months
This study is a pilot, open-label, randomized clinical trial designed to evaluate the feasibility, safety, and effectiveness of rapidly starting multiple guideline-recommended therapies in people with type 2 diabetes and chronic kidney disease.
In current clinical practice, these medicines are usually started one at a time over many months. This step-by-step approach may delay potential benefits and leave people at continued risk of kidney disease progression and cardiovascular complications. This study will test a different approach, where these therapies are started in a structured and closely monitored way over a short period of time.
Participants will be randomly assigned to either a rapid initiation strategy or usual care. In the rapid group, up to four approved therapies will be started and adjusted over approximately 8 weeks using a structured treatment plan. In the usual care group, treatment will follow standard clinical practice, where medications are introduced gradually at the discretion of the treating clinician.
Participants in both groups will be followed for 6 months. During this time, they will have regular clinic visits and laboratory testing to monitor kidney function, potassium levels, and overall treatment tolerance.
This pilot study will provide important information on whether this rapid treatment approach can be safely implemented in real-world clinical settings and whether participants are able to start and continue multiple therapies within a short time frame.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 64 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive all four chronic kidney disease therapies (medications) at the same time.
Drug: Finerenone · Drug: Semaglutide · Drug: Lotensin · Drug: Capoten · Drug: Enalapril · Drug: Monopril · Drug: Lisinopril · Drug: Univasc · Drug: Aceon · Drug: Accupril · Drug: Altace · Drug: Mavik · Drug: Edarbi · Drug: Atacand · Drug: Avapro · Drug: Cozaar · Drug: Benicar · Drug: Micardis · Drug: Diovan · Drug: Invokana · Drug: Farxiga · Drug: Jardiance · Drug: Ertugliflozin · Drug: Brenzavvy · Drug: Sotagliflozin
Subjects received standard of care
Drug: Finerenone · Drug: Semaglutide · Drug: Lotensin · Drug: Capoten · Drug: Enalapril · Drug: Monopril · Drug: Lisinopril · Drug: Univasc · Drug: Aceon · Drug: Accupril · Drug: Altace · Drug: Mavik · Drug: Edarbi · Drug: Atacand · Drug: Avapro · Drug: Cozaar · Drug: Benicar · Drug: Micardis · Drug: Diovan · Drug: Invokana · Drug: Farxiga · Drug: Jardiance · Drug: Ertugliflozin · Drug: Brenzavvy · Drug: Sotagliflozin
10-40mg daily
.25-1.0mg 1 time a week
10-40mg daily
Also known as: Benazepril
12.5-50mg 3 times a day
Also known as: Capotopril
2.5-10mg daily
10-40mg daily
Also known as: Fosinopril
5-20mg daily
3.75-15mg daily
Also known as: Moexipril
4-16mg daily
Also known as: Perindopril
10-40mg daily
Also known as: Quinapril
1.25-5mg daily
Also known as: Ramipril
1-4mg daily
Also known as: Trandolapril
40-80mg daily
Also known as: Azilsartan
8-32mg daily
Also known as: Candesartan Cilexetil
150-300mg daily
Also known as: Irbesartan
25-100mg daily
Also known as: Losartan
20-40mg daily
Also known as: Olmesartan
20-80mg daily
Also known as: Telmisartan
80-320mg daily
Also known as: Valsartan
100mg daily
Also known as: Canagliflozin
10mg daily
Also known as: Dapagliflozin Propanediol
10mg daily
Also known as: Empagliflozin
5mg daily
20mg daily
Also known as: Bexagliflozin
200-400mg daily
Also known as: SAR439954
On-study retention rate at 6 months
Proportion of participants who remain on all four guideline-directed CKD therapies at maximally tolerated doses without permanent discontinuation
Time frame: 6 months
Sustained decline in eGFR ≥30%
Proportion of participants with sustained decline in estimated glomerular filtration rate (eGFR; two consecutive readings ≥2 weeks apart)
Time frame: 6 months
Change in UACR
Relative change in log-transformed urine albumin-to-creatinine ratio (UACR) from baseline to 6 months
Time frame: 6 months
Enrollment rate
Number of participants enrolled per month
Time frame: 6 months
Protocol adherence
Proportion of participants initiating all four therapies within 8 weeks
Time frame: 6 months
Treatment discontinuation
Proportion of participants who permanently discontinue one or more therapies
Time frame: 6 months
Moderate Hyperkalemia
Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L
Time frame: 6 months
Severe Hyperkalemia
Incidence of potassium levels greater than 6.0 mmol/L
Time frame: 6 months
Acute Kidney Injury
Incidence of acute kidney injury (AKI) events (persistent estimated glomerular filtration rate decline ≥30% without return to \<30% with drug discontinuation; or hospitalization with diagnosis of AKI related to medications) during the study period
Time frame: 6 months
End-stage kidney disease
Incidence of progression to end-stage kidney disease (initiation of chronic dialysis \[hemo- or peritoneal dialysis\] for ≥90 days or kidney transplantation, or persistent \[≥2 values, including the last value if not on dialysis or transplant\] estimated glomerular filtration rate \<15 mL/min/1.73m\^2)
Time frame: 6 months
Number of participants with permanent drug discontinuation
Number of participants with permanent discontinuation of one or more study drugs not due to study completion or death.
Time frame: 6 months
Rate of change in estimated glomerular filtration rate (slope)
Rate of change in estimated glomerular filtration rate over the 6-month study period
Time frame: 6 months
Change in glycated hemoglobin (HbA1c)
Change in glycated hemoglobin (HbA1c) levels from baseline
Time frame: 6 months
Number of participants who achieve >30% reduction in urine albumin-to-creatinine ratio
Number of participants achieving \>30% reduction in urine albumin-to-creatinine ratio
Time frame: 6 months
Change in Kidney Disease Quality of Life-36 score
Change from baseline in Kidney Disease Quality of Life-36 (KDQOL-36) score. Scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: 6 months
Change in Patient-Reported Outcomes Measurement Information System score
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score. PROMIS includes seven domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Each domain includes 4 items scored from 1 to 5, with raw domain scores ranging from 4 to 20, and domain scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. A separate Pain Intensity item is rated on a 0 to 10 scale, where 0 indicates no pain and 10 indicates worst imaginable pain. For Physical Function and Ability to Participate in Social Roles and Activities, higher scores indicate better health. For Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity, higher scores indicate greater symptom burden or worse health status.
Time frame: 6 months
Change in Treatment Burden Questionnaire (TBQ) score
Change from baseline in Treatment Burden Questionnaire (TBQ) score. TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem) to 10 (big problem) and assesses the burden associated with taking medicine, self-monitoring, laboratory tests, doctor visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. TBQ item scores can be summed into a global score, ranging from 0 to 130. Higher scores indicating greater treatment burden.
Time frame: 6 months
Change in Living with Medicines Questionnaire version 3 score
Change from baseline in Living with Medicines Questionnaire version 3 (LMQ-3) score. LMQ-3 consists of 41 items scored on a 5-point Likert scale. Total scores range from 41 to 205, with higher scores indicating greater treatment burden.
Time frame: 6 months
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in this study, after deidentification, will be shared. Shared data will include patient-level clinical and laboratory data, along with a data dictionary (README file) to facilitate interpretation. Data will be made available through the Vivli data sharing platform. Prior to external sharing, all data will undergo internal review to ensure removal of identifiable information and compliance with institutional legal and ethical requirements. Data will be available for a minimum of 10 years and access will be provided in accordance with participant informed consent and applicable regulatory and institutional policies.
Supporting information: Study protocol
Time frame: Data will become available after publication of the primary results and will remain available on Vivli for a minimum of 10 years.
Access criteria: Access will be provided to qualified researchers through the Vivli data sharing platform. Prior to sharing, all data will undergo internal review to ensure removal of identifiable information and compliance with institutional legal and ethical requirements. Data sharing will be conducted in accordance with participant informed consent and applicable regulatory and institutional policies.
Started Apr 2026 (actual). Primary completion is estimated for Mar 2029, 35 months after the start.
Of 100 non-industry phase 4 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 67. This study's planned 35 months is below that.
Counting every sponsor, half of 116 studies reached it within 43 months; a quarter within 22 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Finerenone · Semaglutide · Benazepril · Captopril · Enalapril · Fosinopril · Lisinopril · Moexipril · Perindopril · Quinapril · Ramipril · Trandolapril · Azilsartan medoxomil · Candesartan cilexetil · Irbesartan · Losartan · Olmesartan Medoxomil · Telmisartan · Valsartan · Canagliflozin · Dapagliflozin · Empagliflozin · Ertugliflozin · Bexagliflozin · Sotagliflozin
Renal Insufficiency, Chronic →