Apelin as a Potential Treatment for Chronic Kidney Disease

What Was Tested

The trial (not phased) is built around Apelin.

It had two arms (groups): one (active comparator) and Healthy volunteers (active comparator).

The registry classes the interventions as other.

More on the Plan

The apelins are a family of peptides whose most abundant isoform is \[Pyr1\]apelin-13.

This binds to a single G protein coupled receptor known as 'APJ', which is widely expressed particularly in endothelium and cardiomyocytes.

Apelin is the most powerful inotropic agent discovered to date, and apelin infusion into healthy humans leads to endothelium-dependent vasodilatation and BP lowering.

Given its vasodilatory and inotropic effects, apelin is being investigated as a novel therapy for heart failure and pulmonary arterial hypertension, both of which are features of CKD.

Who Took Part

46 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Clinically optimised on an angiotensin converting enzyme inhibitor / angiotensin receptor blocker, or intolerant to these agents.

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: age \<18 years; diabetes mellitus; overt cardiovascular disease.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this Apelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Apelin and the comparison in turn, acting as their own control.

As a double-blind Apelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-02-04 with completion listed for 2022-12-14.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change in forearm blood flow (time frame: 1 hour). Change in renal blood flow (time frame: 4 hours).

It also tracked 6 secondary outcomes, for example Change in arterial stiffness, Change in natriuresis, Change in diuresis, Change in blood pressure, Change in proteinuria and Change in chorioretinal metrics as assessed by optical coherence tomography (OCT.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Apelin in 46 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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