A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Kidney Transplantation

In brief

The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.

Key facts

Study ID

NCT01442337

Run by

Astellas Pharma Inc

People needed

21

Starts

2011-12-01

Expected to finish

2013-07-01

Last updated by the study team

2014-06-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is scheduled to receive a kidney transplant from a deceased donor meeting at least one of the following criteria:
• Expanded Criteria Donor (ECD)
• i Donor was > 60 years of age, OR
• ii. Donor was 50-59 years of age, inclusive, and met at least two of the following criteria:
• Donor died of a cerebral bleed
• Donor had a history of hypertension
• Donor's terminal serum creatinine concentration was > 1.5 mg/dL
• Donation after Cardiac Death (DCD) - Donor was pronounced dead prior to procurement of the kidney
• Standard Criteria Donor (SCD)
• i. Donor with terminal serum creatinine < 1.5 mg/dL where kidney is anticipated to have a minimum of 24 hours of cold ischemia prior to transplantation, OR
• ii. Donor with terminal serum creatinine > 1.5 mg/dL and any cold ischemic time up to exclusion limit
• Female subject is not pregnant and agrees to use an acceptable form of contraception throughout study
• Male subject agrees to use an adequate method of contraception and agrees to no sperm donation throughout the study

You may not qualify if…

• Female subject is pregnant or lactating
• Donor kidney is anticipated to have more than 40 hours of cold ischemia time
• Donor is > 66 years of age
• Donor meets both DCD and ECD criteria
• Subject has previously received, or is receiving an organ transplant other than a kidney
• Subject has a positive T or B cell crossmatch by the investigational site's standard method of determination. For recipients where only a flow cytometry crossmatch is performed and is positive in either T or B cell testing, recipients are excluded only if donor specific, anti-HLA antibody is detected by flow cytometry based, specific anti-HLA antibody testing
• Subject has ABO blood type incompatibility with his/her organ donor
• Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)
• Subject has a known bleeding diathesis
• Subject has a International Normalized Ratio (INR) > 1.5 times upper limit of normal at Screening
• Subject has a platelet count < 100,000 platelets/µL at Screening
• Subject used anti-platelet agents [e.g., Plavix® (clopidogrel bisulfate), Brilinta® (ticagrelor)] (with the exception of aspirin < 100 mg/day for cardiovascular prophylaxis), anti-coagulants [e.g., Pradaxa® (dabigatran), Xarelto® (rivaroxaban)], anti-thrombotics, and/or blood-thinning agents within the 10 days prior to Screening; and/or subject is expected to require use of any of these agents during the first 15 days of the study period (with the exception of standard of care peri-operative administration of heparin for DVT prophylaxis)
• Subject has an uncontrolled concomitant infection
• Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
• Subject currently is participating in an investigational drug study, or participated in an investigational drug study within the last 30 days)
• Subject has a history of or is believed to have used an illicit drug(s) and/or abused alcohol within the last 3 months
• Subject has an unstable psychiatric illness
• Subject has previously received ASP8597 or participated in a study involving ASP8597

Where it is running

• St. Vincent Medical Center — Los Angeles, California, United States
• Sharp Memorial — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• St. Barnabas Medical Center — Livingston, New Jersey, United States
• New York Presbyterian Hospital — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Pinnacle Health at Harrisburg — Harrisburg, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Baylor All Saints Medical Center — Fort Worth, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.