At a glance
ClinicalIndex Comparison Record- ✓Receiving hemodialysis regularly at least 3 times per week for at least 4 months
- ✓Hemoglobin 9.5–11.0 g/dL at screening (taken prior to dialysis if on a dialysis day)
- ✓Currently receiving ESA injections for at least 4 weeks and willing to stop for approximately 8 weeks
- ✕Another health condition that may put participant at risk or deemed unsuitable by study doctor
- ✕Currently enrolled in another clinical study
- ✕Completed another study or previously enrolled in this study within 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis
In Brief
A Phase 1 clinical trial evaluating LY3113593 and Placebo for Chronic Kidney Disease. Completed, enrolled 7 participants across 5 sites.
Detailed Summary
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body. The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.
Study Details
Timeline
Interventions
Administered by slow intravenous (IV) infusion.
Administered by slow intravenous (IV) infusion.