A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis

What Was Tested

The trial (phase 2) is built around GHRP-1.

Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients.

The registry classes the interventions as drug and other.

More on the Plan

This is a randomized, cross-over, double-blind, vehicle-controlled study.

Each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up.

Treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule.

The total duration of study participation will be 12 weeks.

Who Took Part

3 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Subjects who are 18 to 70 years of age.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: subjects who have diabetes and are currently taking insulin; subjects who have active infection at baseline; subjects who have active or unstable cardiac or arterial disease.

How the Study Was Run

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

The participants were allocated by chance, so the GHRP-1 group and the comparison group should start out alike.

Each person switched between GHRP-1 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 GHRP-1.

It started in 2006-09 with completion listed for 2007-05.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Vital signs. ECG. clinical chemistry and hematology.

It also tracked 5 secondary outcomes, for example IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations, GHRP-1 and des-Ala-GHRP-1 plasma concentrations, adverse events, concomitant medications and endocrine parameters.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of GHRP-1 in 3 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 GHRP-1 compound page, all human trials.