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Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.

Abstract：

BACKGROUND:Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. METHODS:We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. CONCLUSION:GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

Mehta A,Mavromatis K,Ko YA,Rogers SC,Dhindsa DS,Goodwin C,Patel R,Martini MA,Prasad M,Mokhtari A,Hesaroieh IG,Frohwein SC,Kutner MH,Harzand A,Wells BJ,Duwayri Y,Alabi O,Rajani RR,Brewster LP,Waller EK,Quyyumi AA

doi

10.1016/j.cct.2020.105975

subject

Has Abstract

pub_date

2020-04-01 00:00:00

pages

105975

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(20)30053-7

journal_volume

pub_type

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Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.