Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients

What Was Tested

In this not phased trial, researchers set out to test MK-677 (Ibutamoren).

It had two arms (groups): MK-0677 then Placebo (experimental) and Placebo then MK-0677 (experimental).

MK-0677 and Placebo - All subjects were given MK-0677 for a 30 +/- 7 days and then they were given a placebo for 30 +/- 7 days.

MK-0677 and Placebo - All subjects were given Placebo for a 30 +/- 7 days and then they were given MK-0677 for 30 +/- 7 days.

The registry classes the interventions as drug.

More on the Plan

Its effects in CKD and ESRD are unknown.

The researchers will study the effects of MK-0677 on renal patients.

Subjects will be ESRD hemodialysis patients.

This protocol is an investigator-initiated, randomized, double-blind crossover, placebo-controlled pilot study.

Who Took Part

The registry lists 49 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

The full record lists 0 inclusion and 28 exclusion criteria; among the exclusions: body mass index greater than 35 kg/m2, or morbid obesity; uncontrolled hyperthyroidism, defined as a tsh less than the lower limit of normal and an elevated free t4, when tested at baseline; hemoglobin \<10 gm/dl.

How the Study Was Run

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

Because people in this MK-677 (Ibutamoren) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between MK-677 (Ibutamoren) 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 MK-677 (Ibutamoren).

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

It started in 2006-08 with completion listed for 2009-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level (time frame: Baseline and after 30 days of intervention).

It also tracked 12 secondary outcomes, for example Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level, Change in Leptin After 30 Days of Intervention Compared to Baseline Level, Change in Insulin After 30 Days of Intervention Compared to Baseline Level, Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level, Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level and Change in CRPs After 30 Days of Intervention Compared to Baseline Level.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of MK-677 (Ibutamoren) in 49 people.

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

More context: the MK-677 (Ibutamoren) compound page, all human trials.