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

This study has been terminated.
(Study was terminated by sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01442337
First received: September 16, 2011
Last updated: June 17, 2014
Last verified: June 2014

September 16, 2011
June 17, 2014
December 2011
July 2013   (final data collection date for primary outcome measure)
  • Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Estimated glomerular filtration rate (eGFR) using abbreviated Modified Diet in Renal Disease (MDRD) formula - Part 2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Part 2 efficacy variable
Same as current
Complete list of historical versions of study NCT01442337 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic variable for ASP8597: Time to attain Cmax (Tmax) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Pharmacokinetic variable for ASP8597: Clearance (CL) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Pharmacokinetic variable for ASP8597: Volume of Distribution (Vz) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Pharmacokinetic variable for ASP8597: Apparent terminal elimination half-life (t1/2) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Part 1 PK variable
  • Requirement of dialysis within the first 7 days post transplant - Part 1 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Part 1 efficacy variable
  • eGFR using abbreviated MDRD formula - Part 1 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Part 1 efficacy variable
  • Requirement of dialysis within the first 7 days post transplant - Part 2 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Part 2 efficacy variable
  • Patient survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Part 2 efficacy variable
  • Graft survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Part 2 efficacy variable
  • Biopsy-proven acute rejection (BPAR) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Part 2 efficacy variable
  • Clinically treated rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects who receive immunosuppressive medications for the treatment of suspected or biopsy-proven acute rejection. Part 2 efficacy variable
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study (Part 1 Open-Label) to Assess the Safety, Efficacy and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de Novo Kidney Transplant Recipients

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

This is a two-part study. Part 1 (Phase 2) has completed enrollment. Subjects are currently being followed per protocol. Data from Part 1 will be used to determine the doses used in Part 2 (Phase 3). Part 2 will enroll approximately 573 subjects and is planned to have 2 doses of ASP8597 (low dose and either the high or highest dose) along with placebo.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: ASP8597
    one time IV dose
    Other Name: diannexin
  • Drug: Placebo
    one time IV dose
  • Experimental: ASP8597 low dose
    Intervention: Drug: ASP8597
  • Experimental: ASP8597 high dose
    Intervention: Drug: ASP8597
  • Experimental: ASP8597 highest dose
    Intervention: Drug: ASP8597
  • Placebo Comparator: Placebo
    Placebo comparator used in Part 2 only
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is scheduled to receive a kidney transplant from a deceased donor meeting at least one of the following criteria:

    1. 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:

        1. Donor died of a cerebral bleed
        2. Donor had a history of hypertension
        3. Donor's terminal serum creatinine concentration was > 1.5 mg/dL
    2. Donation after Cardiac Death (DCD) - Donor was pronounced dead prior to procurement of the kidney
    3. 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

Exclusion Criteria:

  • 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01442337
8597-CL-0201
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP