Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/5/2014 |
| Start Date: | May 2013 |
| End Date: | August 2014 |
| Contact: | Hideyuki Yamamoto |
| Email: | yamamoto@akrospharma.com |
| Phone: | 609-919-6111 |
Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),
and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days
in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days
in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
Inclusion Criteria:
- Subjects who have ESRD and have been receiving maintenance hemodialysis for at least
12 weeks prior to the Screening Visit
- Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between
20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
- Hemoglobin value as defined in the protocol
- Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening
Visit as defined in the protocol
Exclusion Criteria:
- Transferrin saturation and ferritin levels at the Screening Visit as defined in the
protocol
- Anemia due to known causes other than chronic kidney disease
- Known history of hyporesponsiveness to ESAs
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to
Screening visit
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials