Mitochondria and Chronic Kidney Disease

What Was Tested

The trial (phase 2) is built around Icatibant.

The overarching goal of this study is to determine the role of chronic kidney disease and the activation of the kallikrein-kinin system during hemodialysis on the development of mitochondrial dysfunction; the investigators will measure mitochondrial function using the gold standard method, 31-phosphorus magnetic resonance spectroscopy.

The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial dysfunction in patients undergoing hemodialysis.

The investigators will first perform a randomized, placebo-controlled, double-blind, cross-over study measuring the effect of Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.

It had two arms (groups): Icatibant then Placebo (experimental) and Placebo then Icatibant (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 11 actual participants took part.

It was open to people of any sex aged from 18 years up to 78 years.

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

Examples of who could join: Adult patients who have been on maintenance hemodialysis for at least 6 months.

The full record lists 1 inclusion and 15 exclusion criteria; among the exclusions: history of functional transplant less than 6 months prior to study; use of immunosuppressive drugs within 1 month prior to study; history of active connective tissue disease.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

The participants were allocated by chance, so the Icatibant group and the comparison group should start out alike.

Each person switched between Icatibant and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Icatibant.

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

It started in 2017-08-01 with completion listed for 2018-06-30.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) (time frame: Up to 2 hours after completion of drug infusion).

It also tracked 1 secondary outcome, for example Systolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Icatibant in 11 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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