A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Nov… (NCT01279538) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation
United States50 participantsStarted 2010-11-17
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (H…
What they're measuring
1
Pharmacokinetic assessment through analysis of blood samples