| Trial ID: | L0605 |
| Source ID: | NCT01971164
|
| Associated Drug: |
Jtz-951
|
| Title: |
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia of Chronic Kidney Disease
|
| Interventions: |
DRUG: JTZ-951|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of subjects with adverse events, 15 days|Vital signs and 12 lead ECGs, 15 days|Cmax (maximum concentration), 15 days|tmax (time to reach maximum concentration), 15 days|t1/2 (elimination half-life), 15 days|AUC (area under the concentration-time curve), 15 days|AR (accumulation ratio), 15 days|RBC (red blood cell) count, 15 days|Hgb (hemoglobin), 15 days|TSAT (transferrin saturation), 15 days|serum ferritin, 15 days |
|
| Sponsor/Collaborators: |
Sponsor: Akros Pharma Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
29
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-05
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2014-07-14
|
| Locations: |
Lakewood, Colorado, United States|Miami, Florida, United States|Orlando, Florida, United States|Minneapolis, Minnesota, United States|Saint Paul, Minnesota, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01971164
|
