New kidney drug shows promise in early safety trial
NCT ID NCT01279538
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a single dose of a new drug called ASKP1240 in 50 people who just received a kidney transplant. The goal was to see how the drug moves through the body, how safe it is, and how well it works. Participants were randomly assigned to get the drug or a placebo, and researchers monitored their health closely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
50 people
The number who actually took part.
- Started
-
Nov 2010
- Finished
-
Jan 2012
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for End-stage renal disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Baylor University Medical Center
Dallas, Texas, 75246, United States
-
Beth Israel Deaconess Medical Center, The Transplant Institute
Boston, Massachusetts, 02215, United States
-
California Institute of Renal Research
San Diego, California, 92123, United States
-
California Pacific Medical Center
San Francisco, California, 94115, United States
-
Central Pennsylvania Transplant Associates
Harrisburg, Pennsylvania, 17104, United States
-
Christ Hospital
Cincinnati, Ohio, 45219, United States
-
Duke University Medical Center
Durham, North Carolina, 27710, United States
-
Emory University
Atlanta, Georgia, 30322, United States
-
Loyola University Medical Center
Maywood, Illinois, 60153, United States
-
Methodist University Hospital
Memphis, Tennessee, 38104, United States
-
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
-
Stanford University Medical Center
Palo Alto, California, 94304, United States
-
The Methodist Hospital
Houston, Texas, 77030, United States
-
UCSF Medical Center
San Francisco, California, 94143, United States
-
University of Cincinnati - University Internal Medicine Associates
Cincinnati, Ohio, 45219, United States
-
University of Colorado Denver
Aurora, Colorado, 80045, United States
-
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
-
University of Michigan
Ann Arbor, Michigan, 48109, United States
-
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
-
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
-
University of Wisconsin
Madison, Wisconsin, 53705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a heart drug shield transplant patients from their own medications?
- Can a deep breath and a hint of lemongrass take the sting out of dialysis needles?
- Can better training get doctors to talk about what matters most to dying veterans?
- Can pedaling during dialysis make red blood cells more flexible?
- 30,000 dialysis patients tracked to map what works
- Donated artery grafts tested as lifeline for dialysis patients