A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD.

It had two arms (groups): Standard of care (no intervention) and Biomarker-targeted treatment (experimental).

In the treatment arm, the participants will receive stepwise treatment with one or more study drugs. The choice, order, and number of treatments introduced will be based on the participant's characteristics/risk profile and the response on UACR and UEGF.

The registry classes the interventions as drug.

More on the Plan

Participants will be randomized 1:1 to a biomarker-targeted treatment approach versus standard of care.

Participants will start treatment with one of the three study medications.

The biomarker response of the third drug will be evaluated in the same manner as that of the first two drugs.

Who Took Part

Enrollment: 125 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age ≥ 18 and ≤ 75 years. Ability to communicate with the study staff and understand and sign the informed consent.

The full record lists 4 inclusion and 22 exclusion criteria; among the exclusions: treatment with two or all three of the study drugs; history of pancreatitis at screening; body mass index \< 18.5 kg/m2 at screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2025-06-20 with completion listed for 2028-06.

It ran at 4 sites in Denmark (1), Germany (1), Spain (1) and Sweden (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Chronic eGFR slope (time frame: From week 26 to 104).

It also tracked 3 secondary outcomes, for example Change in eGFR from baseline to end of study, Change in eGFR from baseline to end of treatment and Change in UACR.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 125 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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