NCT02228655 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Babitt JL, Huang FW, Wrighting DM, Xia Y, Sidis Y, Samad TA, Campagna JA, Chung RT, Schneyer AL, Woolf CJ, Andrews NC, Lin HY
Bone morphogenetic protein signaling by hemojuvelin regulates hepcidin expression. Nat Genet. 2006 May;38(5):531-9. Epub 2006 Apr 9.
Babitt JL, Huang FW, Xia Y, Sidis Y, Andrews NC, Lin HY
Modulation of bone morphogenetic protein signaling in vivo regulates systemic iron balance. J Clin Invest. 2007 Jul;117(7):1933-9.
Huang FW, Pinkus JL, Pinkus GS, Fleming MD, Andrews NC
A mouse model of juvenile hemochromatosis. J Clin Invest. 2005 Aug;115(8):2187-91.
KDOQI
KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007 Sep;50(3):471-530.
Theurl I, Schroll A, Sonnweber T, Nairz M, Theurl M, Willenbacher W, Eller K, Wolf D, Seifert M, Sun CC, Babitt JL, Hong CC, Menhall T, Gearing P, Lin HY, Weiss G
Pharmacologic inhibition of hepcidin expression reverses anemia of chronic inflammation in rats. Blood. 2011 Nov 3;118(18):4977-84. doi: 10.1182/blood-2011-03-345066. Epub 2011 Jul 5.
Weiner DE
Causes and consequences of chronic kidney disease: implications for managed health care. J Manag Care Pharm. 2007 Apr;13(3 Suppl):S1-9. Review.
Weiss G, Goodnough LT
Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. Review.

An Exploratory, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With Chronic Kidney Disease (CKD), Stage 4 or 5

Details for clinical trial NCT02228655

Clinical trial NCT02228655 - References