Trial Information

PROTOCOL OUTLINE: This is a multicenter study. Patients receive arginine butyrate IV over
6-14 hours on days 1-5 of weeks 1-4 and 7-10. Patients then receive maintenance arginine
butyrate IV over 6-14 hours on days 1-4 of weeks 13, 15, 17, 19, 21, 23, and 25.

Patients who have no medical contraindications (e.g., paraspinal extramedullary
hematopoiesis, hypertension, or poorly controlled congestive heart failure) may continue
therapy. Patients receive arginine butyrate IV over 6-14 hours on days 1-4 of weeks 27, 29,
31, 33, 35, 37, and 39 and epoetin alfa intramuscularly (IM) or subcutaneously (SC) three
times weekly on weeks 27-40.

Patients may continue to receive epoetin alfa IM or SC alone three times weekly on weeks
41-52. Patients with severe anemia (hemoglobin less than 7 g/dL) may receive epoetin alfa
alone on weeks 1-12 before arginine butyrate induction therapy.

Patients who complete therapy at week 26 are followed every 2 weeks for 2 months. Patients
who complete therapy at week 40 are followed monthly for 2 months.