Kidney TransplantationPhase 1NCT01279538
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
A Phase 1 study testing bleselumab in people with Kidney Transplantation, run by Astellas Pharma Inc at 21 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- bleselumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 21 sitesUnited States
- Study dates
- 17 Nov 2010to 23 Jan 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a recipient of a de novo kidney transplant from a living or deceased donor
- Prior to randomization, the subject has a post-transplant serum creatinine value that is at least 30% decreased from the pre-transplant value and requires no dialysis
- Female subject of child bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment or upon hospitalization and must agree to maintain effective birth control during the study
- All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agrees to no sperm donation until the end of the study, or for 90 days after the last dose of study drug, whichever is longer
- Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions
Who cannot join
- Prior to randomization, subject will receive antibody induction therapy (e.g., thymoglobulin, basiliximab, daclizumab, OKT3, alemtuzumab)
- Subject has previously received or is receiving an organ transplant other than a kidney
- Recipient has a positive T or B cell crossmatch
- Subject has ABO blood type incompatibility with their donor
- Subject has received intravenous immunoglobulin (IVIG) therapy in the 3 months prior to first dose of study drug
- Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)
Show all 17Show fewer
- Subject had a thromboembolic event (e.g., myocardial infarction, cerebrovascular event, pulmonary embolus, deep vein thrombosis, peripheral arterial thromboembolic event) in the past 5 years or if the subject is on specific therapy for prophylaxis or treatment of such an event. Low dose aspirin (81 mg) therapy is not considered exclusionary. NOTE: A one-time event of arterio-venous (AV) fistula dialysis access thrombosis is not exclusionary. Subjects with recurrent AV fistula thrombosis or those on systemic medications to prevent reoccurrence are excluded
- 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 has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
- Subject is concurrently participating in another drug study or has received an investigational drug up to 8 weeks (depending on medication) prior to transplant
- Subject has previously received ASKP1240 or participated in a study involving ASKP1240
- Subject has abnormal chest x-ray indicative of acute or chronic lung disease on a prior examination within 3 months prior to randomization
- Subject has abnormal electrocardiogram (ECG) considered as clinically significant on a prior examination within 3 months prior to randomization
- Subject has uncontrolled intercurrent illness, including, but not limited to ongoing or active infection, any clinically significant cardiac disease, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements
- Subject has received live or live attenuated virus vaccinations within the last 30 days prior to first dose of study drug
- Subject has a clinical condition which would not allow safe conduct and completion of the study
- Subject is pregnant or lactating
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center, The Transplant Institute
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Illinois Medical Center
Chicago, Illinois, 60612
Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati - University Internal Medicine Associates
Cincinnati, Ohio, 45219
Baylor University Medical Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
Central Pennsylvania Transplant Associates
Harrisburg, Pennsylvania, 17104
The Methodist Hospital
Houston, Texas, 77030
St. Barnabas Medical Center
Livingston, New Jersey, 07039
University of Wisconsin
Madison, Wisconsin, 53705
Loyola University Medical Center
Maywood, Illinois, 60153
Methodist University Hospital
Memphis, Tennessee, 38104
Stanford University Medical Center
Palo Alto, California, 94304
University of Utah Hospital
Salt Lake City, Utah, 84132
California Institute of Renal Research
San Diego, California, 92123
California Pacific Medical Center
San Francisco, California, 94115
UCSF Medical Center
San Francisco, California, 94143
About this study
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
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.
- Conditions
- Kidney Transplantation
- Being tested
- bleselumab, Placebo
- Keywords
- Pharmacology, Pharmacokinetics, ASKP1240, Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleselumabDrug
Also called ASKP1240
Intravenous (IV) infusion
PlaceboDrug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| ASKP1240 lowest dose | Experimental | Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. Receives: Drug: bleselumab |
| ASKP1240 low dose | Experimental | Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. Receives: Drug: bleselumab |
| ASKP1240 high dose | Experimental | Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. Receives: Drug: bleselumab |
| ASKP1240 highest dose | Experimental | Participants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. Receives: Drug: bleselumab |
| Placebo | Placebo comparator | Participants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment through analysis of blood samples
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study start17 Nov 2010
- Primary completion23 Jan 2012
- Study completion23 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279538
- Sponsor's protocol ID
- 7163-CL-0103
- Status last verified
- Nov 2025
- First submitted
- 18 Jan 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.
Publications
Vincenti F, Klintmalm G, Yang H, Ram Peddi V, Blahunka P, Conkle A, Santos V, Holman J. A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation. Am J Transplant. 2020 Jan;20(1):172-180. doi: 10.1111/ajt.15560. Epub 2019 Sep 9.
PubMed 31397943
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01279538
- Acronym / sponsor ID
- 7163-CL-0103
- Conditions
- Kidney Transplantation
- Keywords
- Pharmacology, Pharmacokinetics, ASKP1240, Kidney Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd.
- Study start
- 17 Nov 2010 (actual)
- Primary completion
- 23 Jan 2012 (actual)
- Study completion
- 23 Jan 2012 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ASKP1240 lowest dose | Experimental | Drug: bleselumabParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. |
| ASKP1240 low dose | Experimental | Drug: bleselumabParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. |
| ASKP1240 high dose | Experimental | Drug: bleselumabParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. |
| ASKP1240 highest dose | Experimental | Drug: bleselumabParticipants received a single 30-minute study drug infusion on Study Day 1, followed by a 90-day follow-up period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single 30-minute matching placebo infusion on Study Day 1, followed by a 90-day follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a recipient of a de novo kidney transplant from a living or deceased donor
- Prior to randomization, the subject has a post-transplant serum creatinine value that is at least 30% decreased from the pre-transplant value and requires no dialysis
- Female subject of child bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment or upon hospitalization and must agree to maintain effective birth control during the study
- All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agrees to no sperm donation until the end of the study, or for 90 days after the last dose of study drug, whichever is longer
- Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions
Key exclusion criteria (17 listed)
- Prior to randomization, subject will receive antibody induction therapy (e.g., thymoglobulin, basiliximab, daclizumab, OKT3, alemtuzumab)
- Subject has previously received or is receiving an organ transplant other than a kidney
- Recipient has a positive T or B cell crossmatch
- Subject has ABO blood type incompatibility with their donor
- Subject has received intravenous immunoglobulin (IVIG) therapy in the 3 months prior to first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bleselumabAlso: ASKP1240Intravenous (IV) infusion | Drug | ASKP1240 high dose, ASKP1240 highest dose, ASKP1240 low dose, ASKP1240 lowest dose |
| PlaceboIntravenous (IV) infusion | Drug | Placebo |
Primary outcome
Pharmacokinetic assessment through analysis of blood samples
Time frame: Up to Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 31397943Vincenti F, Klintmalm G, Yang H, Ram Peddi V, Blahunka P, Conkle A, Santos V, Holman J. A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation. Am J Transplant. 2020 Jan;20(1):172-180. doi: 10.1111/ajt.15560. Epub 2019 Sep 9.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Medical Director study director
Astellas Pharma Global Development
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bleselumab in people with Kidney Transplantation, run by Astellas Pharma Inc at 21 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 assessment through analysis of blood samples (time frame: Up to Day 90). 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 NCT01279538, which also lists 1 linked publication.
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 17 Nov 2025.