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Kidney TransplantationPhase 2/3NCT01442337

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

A Phase 2/3 study testing ASP8597 in people with Kidney Transplantation, run by Astellas Pharma Inc at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Kidney Transplantation
What is being tested?
ASP8597
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
19 sitesUnited States
Study dates
Dec 2011to Jul 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado

    Aurora, Colorado, 80045

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Duke University

    Durham, North Carolina, 27710

  • Baylor All Saints Medical Center

    Fort Worth, Texas, 76104

  • East Carolina University

    Greenville, North Carolina, 27834

  • Pinnacle Health at Harrisburg

    Harrisburg, Pennsylvania, 17011

  • The Methodist Hospital

    Houston, Texas, 77030

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • St. Vincent Medical Center

    Los Angeles, California, 90057

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • New York Presbyterian Hospital

    New York, New York, 10065

  • Sharp Memorial

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • University of California at San Francisco

    San Francisco, California, 94143

  • Washington University

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
ASP8597, Placebo
Keywords
de novo kidney transplant, kidney transplant, ASP8597, diannexin, ischemia-reperfusion injury
Medical subject headings
Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP8597Drug

    Also called diannexin

    one time IV dose

  • PlaceboDrug

    one time IV dose

Study groups in NCT01442337
Study groupRoleWhat they receive
ASP8597 low doseExperimentalNot described
Receives: Drug: ASP8597
ASP8597 high doseExperimentalNot described
Receives: Drug: ASP8597
ASP8597 highest doseExperimentalNot described
Receives: Drug: ASP8597
PlaceboPlacebo comparatorPlacebo comparator used in Part 2 only
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax)

    Part 1 PK variable

    Measured: 3 days

  2. Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)

    Part 1 PK variable

    Measured: 3 days

  3. Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to infinity (AUCinf)

    Part 1 PK variable

    Measured: 3 days

  4. Estimated glomerular filtration rate (eGFR) using abbreviated Modified Diet in Renal Disease (MDRD) formula - Part 2

    Part 2 efficacy variable

    Measured: 12 months

Secondary outcomes (11)

  1. Pharmacokinetic variable for ASP8597: Time to attain Cmax (Tmax)

    Part 1 PK variable

    Measured: 3 days

  2. Pharmacokinetic variable for ASP8597: Clearance (CL)

    Part 1 PK variable

    Measured: 3 days

  3. Pharmacokinetic variable for ASP8597: Volume of Distribution (Vz)

    Part 1 PK variable

    Measured: 3 days

  4. Pharmacokinetic variable for ASP8597: Apparent terminal elimination half-life (t1/2)

    Part 1 PK variable

    Measured: 3 days

  5. Requirement of dialysis within the first 7 days post transplant - Part 1

    Part 1 efficacy variable

    Measured: 7 days

  6. eGFR using abbreviated MDRD formula - Part 1

    Part 1 efficacy variable

    Measured: 12 months

  7. Requirement of dialysis within the first 7 days post transplant - Part 2

    Part 2 efficacy variable

    Measured: 7 days

  8. Patient survival

    Part 2 efficacy variable

    Measured: 12 months

  9. Graft survival

    Part 2 efficacy variable

    Measured: 12 months

  10. Biopsy-proven acute rejection (BPAR)

    Part 2 efficacy variable

    Measured: 12 Months

  11. Clinically treated rejection

    Subjects who receive immunosuppressive medications for the treatment of suspected or biopsy-proven acute rejection. Part 2 efficacy variable

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJul 2013
  4. Study completionJul 2013

Why it stopped: Study was terminated by sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442337
Sponsor's protocol ID
8597-CL-0201
Status last verified
Jun 2014
First submitted
16 Sep 2011
Last updated
20 Jun 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ASP8597 in people with Kidney Transplantation, run by Astellas Pharma Inc at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was terminated by sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax) (time frame: 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2014.

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