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A Study of LY2928057 in Hemodialysis Participants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991483
First Posted: November 25, 2013
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Renal Insufficiency, Chronic Kidney Disease, Chronic Drug: LY2928057 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline to study completion (approximately 20 weeks) ]
  • Change From Baseline in Hemoglobin at 6 Week Endpoint [ Time Frame: Baseline, 6 weeks ]

Secondary Outcome Measures:
  • Pharmacodynamics (PD): Maximum Change in Hemoglobin (Hb) [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Serum Iron (Fe) Concentrations [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat) [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr) [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Reticulocyte Count [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV) [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH) [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC) [ Time Frame: Baseline through 6 weeks ]
  • Pharmacodynamics (PD): Maximum Change in Ferritin [ Time Frame: Baseline through 6 weeks ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057 [ Time Frame: Pre-dose up to 84 days post last dose ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2928057 [ Time Frame: Pre-dose up to 84 days post last dose ]
  • Number of Participants Who Develop Anti-LY2928057 Antibodies [ Time Frame: Pre-dose up to 84 days post last dose ]
  • Ratio of AUC During Dialysis Versus After Dialysis [ Time Frame: Pre-dose through 14 days post-dose ]

Enrollment: 20
Study Start Date: December 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2928057 (No ESA)
Multiple doses of LY2928057 administered intravenously (IV) either once every 2 weeks (Q2W) or once per week (QW) for 6 weeks. Participants discontinued their personal physician-prescribed erythropoiesis stimulating agent (ESA) before treatment.
Drug: LY2928057
Administered intravenously
Experimental: LY2928057 (Reduced ESA)
Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.
Drug: LY2928057
Administered intravenously
Placebo Comparator: Placebo (No ESA)
Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment.
Drug: Placebo
Administered intravenously
Placebo Comparator: Placebo (Reduced ESA)
Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.
Drug: Placebo
Administered intravenously

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991483


Locations
United States, Colorado
Davita Clinical Research, DN
Lakewood, Colorado, United States, 80228
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32806
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01991483     History of Changes
Other Study ID Numbers: 15268
I5M-MC-FABC ( Other Identifier: Eli Lilly and Company )
First Submitted: November 18, 2013
First Posted: November 25, 2013
Last Update Posted: October 23, 2017
Last Verified: November 2015

Additional relevant MeSH terms:
Kidney Diseases
Chronic Disease
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Disease Attributes
Pathologic Processes