Renal Effects of Intrarenal Nesiritide

What Was Tested

This registered phase 4 trial tested BNP (Nesiritide).

The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation leads to adverse consequences even if the direct renal effects are positive.

Therefore, this study will look at the effects of direct intrarenal administration of nesiritide on GFR and RPF.

It had two arms (groups): 1 (experimental) and 2 (no intervention).

Nesiritide given intrarenally.

No intrarenal drug administration.

The registry classes the interventions as drug.

More on the Plan

The researchers will perform an open-label, parallel arm, controlled study of intrarenal nesiritide in 26 patients hospitalized with CHF.

Patients will be admitted for CHF exacerbation and randomly but equally divided into treatment and placebo groups.

Both arms will receive diuretics on admission as dictated by clinical need.

They will then have an 8-hour diuretic-free period (overnight).

Who Took Part

The registry lists 2 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: Hospitalized for worsening CHF and volume overload. Age greater than or equal to 18 years. NHYA class II-IV at the time of initiation in the study. Signed Informed Consent.

How the Study Was Run

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

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

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

Nothing was hidden in this open-label BNP (Nesiritide) study: the participants and staff both knew the treatment.

It started in 2005-12 with completion listed for 2007-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: GFR (time frame: hours).

It also tracked 3 secondary outcomes, for example Urine output, RPF and sodium excretion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 2 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 BNP (Nesiritide) compound page, all human trials.