DelfaGLP-1 Atlas

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RAPID-CKD

Not yet recruitingPhase 4

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

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

64

estimated

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•eGFR 45-90•UACR ≥200

Primary endpoints

•On-study retention rate•Sustained decline in eGFR ≥30%•UACR, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07547878
Org study ID026-271

Timeline

Milestones

Study first posted2026-04-23actual
Study start2026-04-30estimated
Last update posted2026-05-08actual
Primary completion2029-03-31estimated
Study completion2029-03-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age84 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney
7
Patient-reported / QoL
4
Safety / tolerability / PK
3
Other (unclassified)
3
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in glycated hemoglobin (HbA1c)

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

7 endpoints
Primary/protocol endpoint

Sustained decline in eGFR ≥30%

Time frame:6 months

threshold achievement, event

LOINC 98979-8

Primary/protocol endpoint

Change in UACR

Time frame:6 months

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint/low confidence

Severe Hyperkalemia

Time frame:6 months

threshold achievement, event

Secondary/protocol endpoint/low confidence

Acute Kidney Injury

Time frame:6 months

time to event, event

componentseGFR, change, All-cause hospitalization

Secondary/protocol endpoint

End-stage kidney disease

Time frame:6 months

End-stage renal disease

time to event, event

componentsEnd-stage renal disease, Kidney-replacement therapy, eGFR, change

SNOMED 46177005

Secondary/protocol endpoint

Rate of change in estimated glomerular filtration rate (slope)

Time frame:6 months

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Number of participants who achieve >30% reduction in urine albumin-to-creatinine ratio

Time frame:6 months

uACR, % change

threshold achievement, improvement

LOINC 9318-7

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Change in Kidney Disease Quality of Life-36 score

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient-Reported Outcomes Measurement Information System score

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Treatment Burden Questionnaire (TBQ) score

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Living with Medicines Questionnaire version 3 score

Time frame:6 months

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Treatment discontinuation

Time frame:6 months

Discontinuation due to AE

threshold achievement, event

Secondary/protocol endpoint

Moderate Hyperkalemia

Time frame:6 months

threshold achievement, event

Secondary/protocol endpoint

Number of participants with permanent drug discontinuation

Time frame:6 months

Discontinuation due to AE

event count, event

Other (unclassified)

3 endpoints
Primary/protocol endpoint

On-study retention rate at 6 months

Time frame:6 months

threshold achievement, descriptive

Secondary/protocol endpoint

Enrollment rate

Time frame:6 months

descriptive

Secondary/protocol endpoint

Protocol adherence

Time frame:6 months

threshold achievement, descriptive

Publications (35)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.