Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

What Was Tested

This registered phase 1, phase 2 trial tested SS-31 (Elamipretide).

It had two arms (groups): Bendavia (experimental) and Placebo (placebo comparator).

Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.

The registry classes the interventions as drug.

More on the Plan

The randomization (1:1 active:placebo) was stratified by a diagnosis of diabetes mellitus.

After completion of the PTRA and stenting, subjects were to receive standard treatment.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: ≥40 and ≤80 years old. Have no contraindications to angiography such as severe contrast allergy. Have no contraindications to non-contrast magnetic resonance evaluations such as a pacemaker or magnetically active metal fragments. Able to comply with protocol. Women of childbearing age must:.

The full record lists 15 inclusion and 6 exclusion criteria; among the exclusions: advanced chronic kidney disease defined as either stage 5 or end-stage renal disease requiring dialysis; have received an investigational drug within thirty (30) days of baseline; are pregnant or breast feeding.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the SS-31 (Elamipretide) group and the comparison group should start out alike.

The SS-31 (Elamipretide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on SS-31 (Elamipretide), so expectations could not easily colour the readings.

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

It started in 2012-12 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA (time frame: Baseline (pre-PTRA) and 8 weeks post-PTRA).

It also tracked 8 secondary outcomes, for example Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA, Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA, Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA, Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA, Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA and Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of SS-31 (Elamipretide) in 16 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the SS-31 (Elamipretide) compound page, all human trials.