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Chronic Kidney DiseasePhase 4RAPID-CKDNCT07547878

Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)

A Phase 4 study testing Finerenone, Semaglutide and Lotensin in people with Chronic Kidney Disease and Type 2 Diabetes, run by Baylor Research Institute at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Chronic Kidney Disease, Type 2 Diabetes
What is being tested?
Finerenone, Semaglutide and Lotensin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
8 Apr 2026to 31 Mar 2029
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 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-84 years
  • eGFR 45 to ≤90 mL/min/1.73 m2
  • UACR >200 mg/g
  • diagnosis of T2D
  • receiving ≤2 guideline-recommended drug classes irrespective of dose for ≥4 weeks prior to screening
  • eligible for all 4 drugs
  • systolic BP (SBP) >90 mmHg
  • those willing to provide written informed consent and to adhere to study visits.

Who cannot join

  • Type 1 diabetes
  • any known primary non-diabetic kidney disease (i.e., polycystic kidney disease, glomerulonephritis, interstitial nephritis, etc.)
  • history of kidney transplant
  • liver disease (i.e., aspartate transaminase or alanine transaminase >5 times, or bilirubin >3 times the upper limit of normal)
  • serum potassium >5.5 mEq/L at baseline
  • known hypersensitivity to any study drug
Show all 16Show fewer
  • life expectancy <6 months
  • active malignancy or infection
  • brittle diabetes (defined as severe glycemic instability with hospitalization or emergency care for hypoglycemia or hyperglycemia within the past 6 months)
  • high-risk of hypoglycemia (Clarke or Gold score ≥4)
  • predicted 12-month risk of hypoglycemia related emergency visits or hospitalizations >5% using the Kaiser Permanente hypoglycemia prediction score
  • high dose insulin use (>1 unit/kg/day).
  • RASi: hyperkalemia or angioedema
  • SGLT2i: diabetic ketoacidosis, type 1 diabetes, recurrent genitourinary infections
  • ns-MRA: hyperkalemia
  • GLP1-RA: personal or family history of medullary thyroid carcinoma, known gastroparesis, or pancreatitis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Baylor Scott and White Medical Center- Temple

    Temple, Texas, 76508

Other trials in United States

About this study

Official title: A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

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:

Read more
  • Is it safe to start these medicines over a short period of time?
  • How often do kidney function changes or high potassium levels occur?
  • Does this approach lower protein in the urine (a sign of kidney damage)?
  • How many participants are able to stay on all four medicines over 6 months?

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

Read the detailed description

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.

Being tested
Finerenone, Semaglutide, Lotensin, Capoten, Enalapril
Keywords
Chronic Kidney Disease, Type 2 Diabetes, Rapid Therapy Initiation, Guideline-Directed Medical Therapy, Renin-Angiotensin System Inhibitors, Sodium-Glucose Cotransporter 2 Inhibitors, Non-steroidal Mineralocorticoid Receptor Antagonist, Glucagon-Like Peptide-1 Receptor Agonist, Albuminuria, Estimated Glomerular Filtration Rate, Hyperkalemia
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Albuminuria, Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FinerenoneDrug

    10-40mg daily

  • SemaglutideDrug

    .25-1.0mg 1 time a week

  • LotensinDrug

    Also called Benazepril

    10-40mg daily

  • CapotenDrug

    Also called Capotopril

    12.5-50mg 3 times a day

  • EnalaprilDrug

    2.5-10mg daily

  • MonoprilDrug

    Also called Fosinopril

    10-40mg daily

  • LisinoprilDrug

    5-20mg daily

  • UnivascDrug

    Also called Moexipril

    3.75-15mg daily

  • AceonDrug

    Also called Perindopril

    4-16mg daily

  • AccuprilDrug

    Also called Quinapril

    10-40mg daily

  • AltaceDrug

    Also called Ramipril

    1.25-5mg daily

  • MavikDrug

    Also called Trandolapril

    1-4mg daily

  • EdarbiDrug

    Also called Azilsartan

    40-80mg daily

  • AtacandDrug

    Also called Candesartan Cilexetil

    8-32mg daily

  • AvaproDrug

    Also called Irbesartan

    150-300mg daily

  • CozaarDrug

    Also called Losartan

    25-100mg daily

  • BenicarDrug

    Also called Olmesartan

    20-40mg daily

  • MicardisDrug

    Also called Telmisartan

    20-80mg daily

  • DiovanDrug

    Also called Valsartan

    80-320mg daily

  • InvokanaDrug

    Also called Canagliflozin

    100mg daily

  • FarxigaDrug

    Also called Dapagliflozin Propanediol

    10mg daily

  • JardianceDrug

    Also called Empagliflozin

    10mg daily

  • ErtugliflozinDrug

    5mg daily

  • BrenzavvyDrug

    Also called Bexagliflozin

    20mg daily

  • SotagliflozinDrug

    Also called SAR439954

    200-400mg daily

Study groups in NCT07547878
Study groupRoleWhat they receive
Interventional GroupActive comparatorSubjects receive all four chronic kidney disease therapies (medications) at the same time.
Receives: 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
Control GroupActive comparatorSubjects received standard of care
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. Sustained decline in eGFR ≥30%

    Proportion of participants with sustained decline in estimated glomerular filtration rate (eGFR; two consecutive readings ≥2 weeks apart)

    Measured: 6 months

  3. Change in UACR

    Relative change in log-transformed urine albumin-to-creatinine ratio (UACR) from baseline to 6 months

    Measured: 6 months

Secondary outcomes (15)

  1. Enrollment rate

    Number of participants enrolled per month

    Measured: 6 months

  2. Protocol adherence

    Proportion of participants initiating all four therapies within 8 weeks

    Measured: 6 months

  3. Treatment discontinuation

    Proportion of participants who permanently discontinue one or more therapies

    Measured: 6 months

  4. Moderate Hyperkalemia

    Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L

    Measured: 6 months

  5. Severe Hyperkalemia

    Incidence of potassium levels greater than 6.0 mmol/L

    Measured: 6 months

  6. 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

    Measured: 6 months

  7. 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)

    Measured: 6 months

  8. 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.

    Measured: 6 months

  9. Rate of change in estimated glomerular filtration rate (slope)

    Rate of change in estimated glomerular filtration rate over the 6-month study period

    Measured: 6 months

  10. Change in glycated hemoglobin (HbA1c)

    Change in glycated hemoglobin (HbA1c) levels from baseline

    Measured: 6 months

  11. 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

    Measured: 6 months

  12. 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.

    Measured: 6 months

  13. 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.

    Measured: 6 months

  14. 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.

    Measured: 6 months

  15. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start8 Apr 2026
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

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
Parallel groups
Model description
Participants are randomized in a 1:1 ratio to either a rapid, simultaneous therapy initiation approach or usual care with slow, sequential initiation of therapies.
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547878
Sponsor's protocol ID
026-271
Acronym
RAPID-CKD
Status last verified
Oct 2026
First submitted
17 Apr 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18.

    PubMed 35529086

  • Dalrymple LS, Katz R, Kestenbaum B, Shlipak MG, Sarnak MJ, Stehman-Breen C, Seliger S, Siscovick D, Newman AB, Fried L. Chronic kidney disease and the risk of end-stage renal disease versus death. J Gen Intern Med. 2011 Apr;26(4):379-85. doi: 10.1007/s11606-010-1511-x. Epub 2010 Sep 19.

    PubMed 20853156

  • Collins AJ, Li S, Gilbertson DT, Liu J, Chen SC, Herzog CA. Chronic kidney disease and cardiovascular disease in the Medicare population. Kidney Int Suppl. 2003 Nov;(87):S24-31. doi: 10.1046/j.1523-1755.64.s87.5.x.

    PubMed 14531770

  • Khan MS, Rashid AM, Shafi T, Rangaswami J, Cherney DZI, Butler J. Residual Risk of Adverse Kidney and Cardiovascular Outcomes in Patients with CKD. Clin J Am Soc Nephrol. 2025 Mar 1;20(3):451-454. doi: 10.2215/CJN.0000000588. Epub 2024 Dec 17. No abstract available.

    PubMed 39688924

  • Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121. doi: 10.1056/NEJMoa2403347. Epub 2024 May 24.

    PubMed 38785209

  • Mayer GJ, Wanner C, Weir MR, Inzucchi SE, Koitka-Weber A, Hantel S, von Eynatten M, Zinman B, Cherney DZI. Analysis from the EMPA-REG OUTCOME(R) trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics. Kidney Int. 2019 Aug;96(2):489-504. doi: 10.1016/j.kint.2019.02.033. Epub 2019 Mar 21.

    PubMed 31142441

  • Neuen BL, Oshima M, Perkovic V, Agarwal R, Arnott C, Bakris G, Cannon CP, Charytan DM, Edwards R, Gorriz JL, Jardine MJ, Levin A, Neal B, De Nicola L, Pollock C, Rosenthal N, Wheeler DC, Mahaffey KW, Heerspink HJL. Effects of canagliflozin on serum potassium in people with diabetes and chronic kidney disease: the CREDENCE trial. Eur Heart J. 2021 Dec 21;42(48):4891-4901. doi: 10.1093/eurheartj/ehab497.

    PubMed 34423370

  • Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021 Nov 26;7:e18. doi: 10.15420/cfr.2021.18. eCollection 2021 Mar.

    PubMed 34950508

  • Lin CY, Hammash M, Miller JL, Schrader M, Mudd-Martin G, Biddle MJ, Moser DK. Delay in seeking medical care for worsening heart failure symptoms: predictors and association with cardiac events. Eur J Cardiovasc Nurs. 2021 Jun 29;20(5):454-463. doi: 10.1093/eurjcn/zvaa032.

    PubMed 33580784

  • Adamo M, Pagnesi M, Mebazaa A, Davison B, Edwards C, Tomasoni D, Arrigo M, Barros M, Biegus J, Celutkiene J, Cerlinskaite-Bajore K, Chioncel O, Cohen-Solal A, Damasceno A, Diaz R, Filippatos G, Gayat E, Kimmoun A, Lam CSP, Novosadova M, Pang PS, Ponikowski P, Saidu H, Sliwa K, Takagi K, Ter Maaten JM, Voors A, Cotter G, Metra M. NT-proBNP and high intensity care for acute heart failure: the STRONG-HF trial. Eur Heart J. 2023 Aug 14;44(31):2947-2962. doi: 10.1093/eurheartj/ehad335.

    PubMed 37217188

  • Greene SJ, Butler J, Fonarow GC. Simultaneous or Rapid Initiation of Combination Therapy for Heart Failure With Preserved Ejection Fraction. JAMA Cardiol. 2025 May 1;10(5):407-408. doi: 10.1001/jamacardio.2025.0038.

    PubMed 40042835

  • Neuen BL, Heerspink HJL, Vart P, Claggett BL, Fletcher RA, Arnott C, de Oliveira Costa J, Falster MO, Pearson SA, Mahaffey KW, Neal B, Agarwal R, Bakris G, Perkovic V, Solomon SD, Vaduganathan M. Estimated Lifetime Cardiovascular, Kidney, and Mortality Benefits of Combination Treatment With SGLT2 Inhibitors, GLP-1 Receptor Agonists, and Nonsteroidal MRA Compared With Conventional Care in Patients With Type 2 Diabetes and Albuminuria. Circulation. 2024 Feb 6;149(6):450-462. doi: 10.1161/CIRCULATIONAHA.123.067584. Epub 2023 Nov 12.

    PubMed 37952217

  • Khan MS, Lea JP. Kidney and cardiovascular-protective benefits of combination drug therapies in chronic kidney disease associated with type 2 diabetes. BMC Nephrol. 2024 Aug 1;25(1):248. doi: 10.1186/s12882-024-03652-5.

    PubMed 39090593

  • Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786. doi: 10.2337/dci22-0034.

    PubMed 36148880

  • Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE investigators. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics. Nephrol Dial Transplant. 2025 Aug 1;40(8):1559-1569. doi: 10.1093/ndt/gfaf022.

    PubMed 39916475

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Finerenone, Semaglutide and Lotensin in people with Chronic Kidney Disease and Type 2 Diabetes, run by Baylor Research Institute at 1 site in United States.

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 8 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 13 Oct 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 United States. 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?

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?

On-study retention rate at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547878, which also lists 37 linked publications.

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 13 Oct 2026.

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