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A Study of LY2928057 in Hemodialysis Participants

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

NCT01991483•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Davita Clinical Research, DN

Lakewood, Colorado, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Davita Clinical Research

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

March 7, 2019

Enrollment

ACTUAL participants

Conditions

Renal Insufficiency, ChronicKidney Disease, Chronic

Interventions

LY2928057

DRUG

Placebo

DRUG

Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet (KETO-PROT-ACTION)

NCT07374042

Kidney Disease, Chronic

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RECRUITINGNA

A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

NCT06343727

Kidney FailureFrailty+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY2928057 in Hemodialysis Participants

Inclusion Criteria

Exclusion Criteria

Ketoanalogue Supplementation for Muscle Protection in CKD 4 and 5 Patients With Moderately Low Protein Diet (KETO-PROT-ACTION)

A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

Rutgers University Study of the Genetics of Kidney Disease

Diuretic Testing in Chronic Kidney Disease

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial