Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naïve to erythropoiesis-stimulating agents^*

ABSTRACT

Objective: To evaluate the efficacy and safety of darbepoetin alfa dosed every-other-week (Q2W) to treat anemia in subjects with chronic kidney disease (CKD), not receiving dialysis, who were naïve to erythropoiesis-stimulating agent (ESA) therapy.

Research design and methods: This was an open-label, multicenter, single-arm study enrolling ESA-naïve CKD subjects with baseline hemoglobin (Hb) < 11.0 g/dL. Q2W darbepoetin alfa treatment was initiated at a dose of 0.75 µg/kg and titrated to achieve and maintain Hb levels at 11.0–13.0 g/dL. Treatment was administered from week 1 to week 19.

Main outcome measures: The primary endpoint was the proportion of subjects who achieved Hb ≥ 11 g/dL at any study visit, except in week 1. Hb levels, darbepoetin alfa dose, and safety were also assessed.

Results: Of the 128 subjects who received at least one dose of darbepoetin alfa and of the subjects who completed the study, 118 (92%) and 112 (97%), respectively, achieved a Hb ≥ 11 g/dL in a median time of 5 weeks. Median darbepoetin alfa dose at week 1 and at the time of achieving a Hb ≥ 11 g/dL were 60 and 80 µg, respectively. Darbepoetin alfa was well-tolerated, and short-term adverse events were consistent with those expected in CKD subjects.

Conclusions: This study demonstrates that de novo Q2W darbepoetin alfa was effective in correcting and maintaining Hb levels in ESA-naïve subjects with CKD who were not receiving dialysis. Study limitations, including lack of a control arm for the study and multiple race information for subjects, must be considered in interpreting the results.

Trial registration: ClinicalTrials.gov identifier: NCT00112008.

Key words: :

• Anemia
• Chronic kidney disease
• Darbepoetin alfa
• Erythropoietin
• Extended dosing

Acknowledgments

Declaration of interest: This study (Aranesp 20030237) was supported by Amgen Inc., Thousand Oaks, CA, USA. M. R. S. has received consultation fees from Amgen Inc and Shire Pharmaceuticals, and speaker honoraria from Amgen Inc. R. G. serves on the Speaker's Bureau for Amgen Inc and Watson Pharmaceuticals. C. Y. C., R. K., and C. S-B. are employees of Amgen Inc. Some patients for this study were enrolled through the Veterans Administration Medical Center (Salem VA Medical Center, Salem, VA, USA and John D. Dingell VA Medical Center, Detroit, MI, USA). For M.R.S., this clinical trial was conducted through the General Clinical Research Center supported by the National Center for Research Resources, a component of the National Institutes of Health (Grant Number M01 RR000080). The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR or NIH. The authors acknowledge Yeshi Mikyas, PhD, Amgen Inc., and Mandy Wyles, on behalf of Amgen Inc., for assistance in writing this manuscript. Trial registration of the 20030237 protocol: http://www.clinicaltrials.gov/ct2/show/NCT00112008?term=20030237&rank=1

The following investigators (listed alphabetically) enrolled patients for this study:

Abu-Hamdan D, Detroit, MI; Agarwal AK, Columbus OH; Albarracin C, Corpus Christi, TX; Anger M, Thornton, CO; Cheriyan R, Fairfax, VA; Coplin RE, Birmingham, AL; Dewberry FL, Clearwater, FL; Dy G, Mansfield, PA; Fadda G, San Diego, CA; Fitz-Patrick D, Honolulu, HI; Flick R, Mesa, AZ; Geronemus R, Lauderdale Lakes, FL; Hamilton M, Ft. Lauderdale, FL; Handelsman S, Atlanta, GA; Hertel J, Augusta, GA; Hura C, San Antonio, TX; Iranmanesh A, Salem, VA; Jackson TL, Beaver, PA; Jones ER, Philadelphia, PA; Kapatkin K, Brandon, FL; Kipnes MS, San Antonio, TX; Kopyt N, Allentown, PA; Krause M, Little Rock, AR; Leiserowitz M, Las Vegas, NV; Liljenquist J, Idaho Falls, ID; Ling BN, Asheville, NC; Mayeda SO, Orange, CA; Navarro JO, Tampa, FL; Ogundipe A, Marietta, GA; Pride ET, North Charleston, SC; Reed JE, Columbus, MS; Silver MR, Cleveland, OH; Walczyk M, Protland, OR; Weinberg MS, Providence, RI; Weissman PN, Miami, FL; Zeig S, Pembroke Pines, FL.

Notes

* The data in this paper were previously presented as the abstract, Silver MR, Agarwal AK, Walczyk MH, et al. Every-other-week (Q2W) Aranesp® (Darbepoetin alfa) dosing in patients with chronic kidney disease (CKD) not receiving dialysis. The American Society of Nephrology Renal Week 2005. November 8–13, 2005, Philadelphia, PA, USA

* Aranesp, Amgen Inc., Thousand Oaks, CA, USA