The protocol called for administration of six weekly intravenous infusions of either basic Fibroblast Growth Factor or placebo in a double-blinded design for treatment of peripheral arterial disease. The first infusion was administered as an inpatient with cardiac monitoring and hourly vital signs to assess for hemodynamic changes. Subsequent infusions were administered on an outpatient basis in the CRC. Study drug efficacy was measured comparing pre-infusion leg plethysmography and treadmill walking times to the same values after six infusions. Pharmacokinetics and safety laboratory bloods tests were assessed weekly. Study design called for an interim analysis. When this was done, it was discovered that 25% of basic Fibroblast Growth Factor recipients developed transient, reversible proteninuria. With this discovery, the protocol was halted by the sponsor.
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