WP3

TerminatedPhase 2

Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study

Lead sponsor

Iain Bressendorff

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Chronic kidney disease, Type 2 diabetes

Eligibility highlights

•eGFR ≥30•UACR ≥2

Primary endpoint

•UACR, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05897372

Org study IDPRIMETIME - WP3

Timeline

Milestones

Study first posted2023-06-09actual

Study start2023-08-01actual

Primary completion2024-09-23actual

Study completion2024-09-23actual

Last update posted2024-09-25actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years

•Diagnosis of diabetes mellitus type 2 (American Diabetes Association / European Association for the Study of Diabetes (ADA/EASD) definition)10

•Biopsy-proven diabetic nephropathy

•UACR ≥ 2,000 mg/g or

•UACR ≥ 1,500 mg/g if treated with sodium-glucose cotransporter 2 inhibitor (SGLT2i)

•Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

•Negative pregnancy test and use of highly effective and safe contraception

•Able to give informed consent.

Exclusion criteria

•Kidney transplant recipient

•Findings on kidney biopsy suggestive of other or concomitant glomerulonephritis (findings associated with hypertensive nephropathy are not exclusion criteria).

•Plasma potassium at baseline > 5.2 mmol/L.

•Active malignancy (basal or squamous cell skin carcinoma, localised prostate cancer, and cancer with no signs of reoccurrence after 5 years are exempt from this).

•Systolic heart failure with NYHA class III-IV.

•Liver failure classified as Child-Pugh C.

•Primary hyperaldosteronism.

•Previous cerebral or retinal haemorrhage.

•Biliary obstructive disorders.

•Acute myocardial infarction within the last three months.

•Severe cardiac arrhythmias.

•Clinically active gout.

•Plasma sodium at baseline < 135 mmol/L.

•Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.

•Treatment with potent CYP3A4 inhibitors.

•Participation in other interventional trials.

•Allergy towards one of more of the drugs to be used during the trial

Endpoints (12)

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

Safety / tolerability / PK

Cardiometabolic biomarkers

Renal / kidney

7 endpoints

Primary/protocol endpoint

urine albumin/creatinin-ratio (UACR) reduction to less than 50% of baseline

Time frame:after 9 months of treatment

uACR, % change

threshold achievement, improvement

LOINC 9318-7

Secondary/protocol endpoint

UACR reduction to less than 70% of baseline

Time frame:after 9 months of treatment

uACR, % change

threshold achievement, improvement

LOINC 9318-7

Secondary/protocol endpoint

UACR less than 300

Time frame:after 9 months of treatment

threshold achievement, improvement

LOINC 9318-7

Secondary/protocol endpoint

difference in UACR

Time frame:after 9 months of treatment

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

difference in UACR

Time frame:after 10 months of treatment (1 month off study drugs)

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

difference in eGFR

Time frame:after 9 months of treatment

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

difference in eGFR

Time frame:after 10 months of treatment (1 month off study drugs)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint/low confidence

difference in systolic and diastolic blood pressure

Time frame:after 9 months of treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

difference in systolic and diastolic blood pressure

Time frame:after 10 months of treatment (1 month off study drugs)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

incidence of plasma potassium >5.5 mmol/L

Time frame:after 9 months of treatment

threshold achievement, event

Secondary/protocol endpoint

incidence of plasma potassium >6.0 mmol/L

Time frame:after 9 months of treatment

threshold achievement, event

Secondary/protocol endpoint

incidence of symptomatic hypotension

Time frame:after 9 months of treatment

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.