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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Collaborator: |
Kyowa Hakko Kirin Company, Limited |
| Information provided by (Responsible Party): | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01279538 |
Purpose
The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Drug: ASKP1240 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 1b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Single-Dose, Pharmacokinetic, Pharmacodynamic, Safety, and Tolerability Study of ASKP1240 in de Novo Kidney Transplantation |
| Enrollment: | 46 |
| Study Start Date: | November 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ASKP1240 lowest dose |
Drug: ASKP1240
Intravenous (IV) infusion
|
| Experimental: ASKP1240 low dose |
Drug: ASKP1240
Intravenous (IV) infusion
|
| Experimental: ASKP1240 high dose |
Drug: ASKP1240
Intravenous (IV) infusion
|
| Experimental: ASKP1240 highest dose |
Drug: ASKP1240
Intravenous (IV) infusion
|
| Placebo Comparator: Placebo |
Drug: Placebo
Intravenous (IV) infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94304 | |
| California Institute of Renal Research | |
| San Diego, California, United States, 92123 | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94143 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| University of Colorado Denver | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center, The Transplant Institute | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New Jersey | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University of Cincinnati - University Internal Medicine Associates | |
| Cincinnati, Ohio, United States, 45219 | |
| Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Pennsylvania | |
| Central Pennsylvania Transplant Associates | |
| Harrisburg, Pennsylvania, United States, 17104 | |
| United States, Tennessee | |
| Methodist University Hospital | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Hospital | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
| Study Director: | Senior Medical Director | Astellas Pharma Global Development |
More Information
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01279538 History of Changes |
| Other Study ID Numbers: | 7163-CL-0103 |
| Study First Received: | January 18, 2011 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Kidney Transplantation Pharmacokinetics Pharmacology ASKP1240 |