A Study of LY2928057 in Hemodialysis Participants



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:December 2013
End Date:October 2015

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A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Hemodialysis Patients

This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in
hemodialysis participants. This study will involve multiple doses of LY2928057 given during a
6 week period either after a participant discontinues or reduces treatment to stimulate red
blood cells. This study will last up to 26 weeks for each participant.


Inclusion Criteria:

- Participants having end-stage renal disease (ESRD), have received an erythropoiesis
stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been
receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks
prior to screening (that is, an approximate Kt/V greater than 1.1 (K equals dialyzer
clearance of urea, t equals dialysis duration time, V equals volume of distribution of
urea, which is approximately equal to the participant's total body water) based on the
clinical judgment of participant's nephrologist and investigator and who are willing
to stop (Parts A and B) or reduce (Part C) their stable ESA dose from the week of
randomization until completion of the 6-week treatment period (unless rescue therapy
is needed)

- Have a hemoglobin value (taken prior to dialysis if taken on a dialysis day) greater
than or equal to 9.5 grams per deciLiter (g/dL) and less than or equal to 12.5 g/dL at
screening

- Have a body mass index (BMI) of 18.5 to 45 kilograms per square meter (kg/m^2)
inclusive at screening

- Have a transferrin saturation (TSat) greater than or equality to 15 percent and
ferritin greater than 40 nanograms per milliliter (ng/mL) at screening

Exclusion Criteria:

- Any cause of anemia other than renal disease

- A history of hyporesponsiveness to ESA
We found this trial at
4
sites
825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Lakewood, Colorado 80228
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Lakewood, CO
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