PK of Serelaxin in Severe Renal Impairment and ESRD

What Was Tested

The trial (phase 1) is built around Relaxin (Serelaxin).

It had four arms (groups): Group 1 Treatment with serelaxin (experimental), Group 2 Treatment with serelaxin (experimental), Group 3 Treatment with serelaxin (experimental) and Group 4 Treatment with serelaxin (experimental).

Patients with severe renal impairment will receive a single 4 hour i.v. infusion of serelaxin.

Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and dialysis will be done on the day of treatment.

Patients with end stage renal disease will receive a single 4 hour i.v. infusion of serelaxin and treatment and PK will be done in dialysis-free interval.

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

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

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

Examples of who could join: Sitting vital signs should be within the following ranges:. Oral body temperature between 35.0-37.5 °C. Systolic blood pressure, 110 to 170 mm Hg. Diastolic blood pressure, 60 to 105 mm Hg. Pulse rate, 45 - 100 bpm.

The full record lists 14 inclusion and 12 exclusion criteria; among the exclusions: pregnant or nursing (lactating) women; sexually active males (incl. vasectomized men) must use a condom during intercourse while taking drug and for 2 weeks after stopping study medication; recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Everyone knew when Relaxin (Serelaxin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-08 with completion listed for 2013-12.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) (time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15). The area under the serum concentration-time curve from time zero to 28 hours after administration (AUC 0-28hr) (time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15). The area under the serum concentration-time curve from time zero to infinity (AUCinf) (time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15).

It also tracked 2 secondary outcomes, for example Percentage of patients developing anti-RLX030 antibodies.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Relaxin (Serelaxin) in 36 people.

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

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

More context: the Relaxin (Serelaxin) compound page, all human trials.