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

What Was Tested

This registered phase 2 trial tested Semaglutide.

The purpose of this trial is to investigate the feasibility and safety of implementing a protocol-based treatment aggressively targeting albuminuria in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria.

It had two arms (groups): Standard of Care (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

However, prior to conducting such a trial it is necessary first to test whether it is even possible to sufficiently lower albuminuria by these means.

Therefore, the researchers wish to first conduct a pilot trial to investigate the feasibility of such an approach.

After 9 months subjects will discontinue protocol drugs and resume their previous medical care.

Who Took Part

1 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Able to give informed consent.

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: kidney transplant recipient; 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2023-08-01 with completion listed for 2024-09-23.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example UACR less than 300, difference in UACR, difference in UACR, difference in eGFR, difference in eGFR and difference in systolic and diastolic blood pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 1 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.