Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis

Summary

The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers.

Timeline

Start

2004-03

Primary completion

2005-11

Completion

2005-11

Publications

• Results Agarwal AK, Silver MR, Reed JE, Dhingra RK, Liu W, Varma N, Stehman-Breen C. An open-label study of darbepoetin alfa administered once monthly for the maintenance of haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis. J Intern Med. 2006 Dec;260(6):577-85. doi: 10.1111/j.1365-2796.2006.01723.x.
• Results Silver MR, Agarwal A, Krause M, Lei L, Stehman-Breen C. Effect of darbepoetin alfa administered once monthly on maintaining hemoglobin levels in older patients with chronic kidney disease. Am J Geriatr Pharmacother. 2008 Jun;6(2):49-60. doi: 10.1016/j.amjopharm.2008.05.002.

Drugs

Indications