Simultaneous Starting of the 4 Guideline Directed CKD Therapies (RAPID-CKD)

NCT07547878 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 026-271
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if starting all four chronic kidney disease therapies at the same time is safe and effective in patients with Type 2 Diabetes and Chronic Kidney Disease. Study hypothesis states that starting all four recommended kidney medications at the same time is safe and effective in reducing albuminuria, a protein in the urine, without a decline in kidney function or increase in potassium levels compared to starting one medication at a time.

Conditions

Chronic Kidney Diseases; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Specific Aim 1

  To assess feasibility (enrollment, retention, adherence, discontinuation). Primary feasibility endpoint: retention at 6 months, defined as remaining on all four therapies at maximally tolerated doses without permanent discontinuation.

  6 months

Secondary Outcomes (1)

• Specific Aim 2

  Baseline to 6 months

Study Arms (2)

Interventional Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Finerenone DRUG

10-40mg daily

Control Group; Interventional Group

Semaglutide DRUG

.25-1.0mg 1 time a week

Control Group; Interventional Group

Lotensin DRUG

10-40mg daily

Also known as: Benazepril

Control Group; Interventional Group

Capoten DRUG

12.5-50mg 3 times a day

Also known as: Capotopril

Control Group; Interventional Group

Enalapril DRUG

2.5-10mg daily

Control Group; Interventional Group

Monopril DRUG

10-40mg daily

Also known as: Fosinopril

Control Group; Interventional Group

Lisinopril DRUG

5-20mg daily

Control Group; Interventional Group

Univasc DRUG

3.75-15mg daily

Also known as: Moexipril

Control Group; Interventional Group

Aceon DRUG

4-16mg daily

Also known as: Perindopril

Control Group; Interventional Group

Accupril DRUG

10-40mg daily

Also known as: Quinapril

Control Group; Interventional Group

Altace DRUG

1.25-5mg daily

Also known as: Ramipril

Control Group; Interventional Group

Mavik DRUG

1-4mg daily

Also known as: Trandolapril

Control Group; Interventional Group

Edarbi DRUG

40-80mg daily

Also known as: Azilsartan

Control Group; Interventional Group

Atacand DRUG

8-32mg daily

Also known as: Candesartan Cilexetil

Control Group; Interventional Group

Avapro DRUG

150-300mg daily

Also known as: Irbesartan

Control Group; Interventional Group

Cozaar DRUG

25-100mg daily

Also known as: Losartan

Control Group; Interventional Group

Benicar DRUG

20-40mg daily

Also known as: Olmesartan

Control Group; Interventional Group

Micardis DRUG

20-80mg daily

Also known as: Telmisartan

Control Group; Interventional Group

Diovan DRUG

80-320mg daily

Also known as: Valsartan

Control Group; Interventional Group

Invokana DRUG

100mg daily

Also known as: Canagliflozin

Control Group; Interventional Group

Farxiga DRUG

10mg daily

Also known as: Dapagliflozin Propanediol

Control Group; Interventional Group

Jardiance DRUG

10mg daily

Also known as: Empagliflozin

Control Group; Interventional Group

Ertugliflozin DRUG

5mg daily

Control Group; Interventional Group

Brenzavvy DRUG

20mg daily

Also known as: Bexagliflozin

Control Group; Interventional Group

Sotagliflozin DRUG

200-400mg daily

Also known as: SAR439954

Control Group; Interventional Group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-84 years
• eGFR 45 to ≤90 mL/min/1.73 m2
• UACR \>200 mg/g
• diagnosis of T2D30
• 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.

You may not qualify if:

• 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)31
• predicted 12-month risk of hypoglycemia related emergency visits or hospitalizations \>5% using the Kaiser Permanente hypoglycemia prediction score32,33
• high dose insulin use (\>1 unit/kg/day).

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Medical Center- Temple

Temple, Texas, 76508, United States

Location

Related Publications (37)

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  BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

finerenone; semaglutide; benazepril; Captopril; Enalapril; Fosinopril; Lisinopril; moexipril; Perindopril; Quinapril; Ramipril; trandolapril; azilsartan; candesartan cilexetil; Irbesartan; Losartan; Olmesartan Medoxomil; olmesartan; Telmisartan; Valsartan; Canagliflozin; dapagliflozin; empagliflozin; ertugliflozin; bexagliflozin; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Peptides; Phosphinic Acids; Organophosphorus Compounds; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds; Imidazoles; Benzimidazoles; Valine; Amino Acids, Branched-Chain; Amino Acids, Essential; Thiophenes; Sulfur Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to 1 of 2 groups; interventional group or control group.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)