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

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:

• 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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Chronic Kidney Disease
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shahzeb Khan, MD; Phone Number: 469-326-2636; Email: shahzeb.khan@bswhealth.org

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott and White Medical Center- Temple
      • Contact: Shahzeb Khan, MD; Phone Number: 469-326-2636; Email: shahzeb.khan@bswhealth.org
      • Principal Investigator: Shahzeb Khan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional Group; Subjects receive all four chronic kidney disease therapies (medications) at the same time.	Drug: Finerenone; 10-40mg daily; Drug: Semaglutide; .25-1.0mg 1 time a week; Drug: Lotensin; 10-40mg daily; Other Names: Benazepril; Drug: Capoten; 12.5-50mg 3 times a day; Other Names: Capotopril; Drug: Enalapril; 2.5-10mg daily; Drug: Monopril; 10-40mg daily; Other Names: Fosinopril; Drug: Lisinopril; 5-20mg daily; Drug: Univasc; 3.75-15mg daily; Other Names: Moexipril; Drug: Aceon; 4-16mg daily; Other Names: Perindopril; Drug: Accupril; 10-40mg daily; Other Names: Quinapril; Drug: Altace; 1.25-5mg daily; Other Names: Ramipril; Drug: Mavik; 1-4mg daily; Other Names: Trandolapril; Drug: Edarbi; 40-80mg daily; Other Names: Azilsartan; Drug: Atacand; 8-32mg daily; Other Names: Candesartan Cilexetil; Drug: Avapro; 150-300mg daily; Other Names: Irbesartan; Drug: Cozaar; 25-100mg daily; Other Names: Losartan; Drug: Benicar; 20-40mg daily; Other Names: Olmesartan; Drug: Micardis; 20-80mg daily; Other Names: Telmisartan; Drug: Diovan; 80-320mg daily; Other Names: Valsartan; Drug: Invokana; 100mg daily; Other Names: Canagliflozin; Drug: Farxiga; 10mg daily; Other Names: Dapagliflozin Propanediol; Drug: Jardiance; 10mg daily; Other Names: Empagliflozin; Drug: Ertugliflozin; 5mg daily; Drug: Brenzavvy; 20mg daily; Other Names: Bexagliflozin; Drug: Sotagliflozin; 200-400mg daily; Other Names: SAR439954
Active Comparator: Control Group; Subjects received standard of care	Drug: Finerenone; 10-40mg daily; Drug: Semaglutide; .25-1.0mg 1 time a week; Drug: Lotensin; 10-40mg daily; Other Names: Benazepril; Drug: Capoten; 12.5-50mg 3 times a day; Other Names: Capotopril; Drug: Enalapril; 2.5-10mg daily; Drug: Monopril; 10-40mg daily; Other Names: Fosinopril; Drug: Lisinopril; 5-20mg daily; Drug: Univasc; 3.75-15mg daily; Other Names: Moexipril; Drug: Aceon; 4-16mg daily; Other Names: Perindopril; Drug: Accupril; 10-40mg daily; Other Names: Quinapril; Drug: Altace; 1.25-5mg daily; Other Names: Ramipril; Drug: Mavik; 1-4mg daily; Other Names: Trandolapril; Drug: Edarbi; 40-80mg daily; Other Names: Azilsartan; Drug: Atacand; 8-32mg daily; Other Names: Candesartan Cilexetil; Drug: Avapro; 150-300mg daily; Other Names: Irbesartan; Drug: Cozaar; 25-100mg daily; Other Names: Losartan; Drug: Benicar; 20-40mg daily; Other Names: Olmesartan; Drug: Micardis; 20-80mg daily; Other Names: Telmisartan; Drug: Diovan; 80-320mg daily; Other Names: Valsartan; Drug: Invokana; 100mg daily; Other Names: Canagliflozin; Drug: Farxiga; 10mg daily; Other Names: Dapagliflozin Propanediol; Drug: Jardiance; 10mg daily; Other Names: Empagliflozin; Drug: Ertugliflozin; 5mg daily; Drug: Brenzavvy; 20mg daily; Other Names: Bexagliflozin; Drug: Sotagliflozin; 200-400mg daily; Other Names: SAR439954

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	6 months
Change in UACR	Relative change in log-transformed urine albumin-to-creatinine ratio (UACR) from baseline to 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Number of participants enrolled per month	6 months
Protocol adherence	Proportion of participants initiating all four therapies within 8 weeks	6 months
Treatment discontinuation	Proportion of participants who permanently discontinue one or more therapies	6 months
Moderate Hyperkalemia	Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L	6 months
Severe Hyperkalemia	Incidence of potassium levels greater than 6.0 mmol/L	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	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)	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.	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	6 months
Change in glycated hemoglobin (HbA1c)	Change in glycated hemoglobin (HbA1c) levels from baseline	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	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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Type 2 Diabetes; Albuminuria; Hyperkalemia; Sodium-Glucose Cotransporter 2 Inhibitors; Guideline-Directed Medical Therapy; Rapid Therapy Initiation; Renin-Angiotensin System Inhibitors; Non-steroidal Mineralocorticoid Receptor Antagonist; Glucagon-Like Peptide-1 Receptor Agonist; Estimated Glomerular Filtration Rate
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Urination Disorders; Urological Manifestations; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Water-Electrolyte Imbalance; Proteinuria; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Hyperkalemia; Albuminuria; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Imidazoles; Indoles; Amino Acids; Benzene Derivatives; Organophosphorus Compounds; Amino Acids, Essential; Amino Acids, Cyclic; Thiophenes; Tetrazoles; Tetrahydroisoquinolines; Isoquinolines; Biphenyl Compounds; Dipeptides; Spiro Compounds; Valine; Amino Acids, Branched-Chain; Proline; Imino Acids; Phosphinic Acids; Valsartan; Olmesartan Medoxomil; Telmisartan; Canagliflozin; Irbesartan; Quinapril; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Ramipril; Losartan; Enalapril; Lisinopril; Captopril; Perindopril; semaglutide; empagliflozin; ertugliflozin; finerenone; dapagliflozin; candesartan cilexetil; azilsartan; bexagliflozin; benazepril; olmesartan; Fosinopril; moexipril; trandolapril
• Other Study ID Numbers: 026-271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will become available after publication of the primary results and will remain available on Vivli for a minimum of 10 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No