Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
NCT ID: NCT00270634
Last Updated: 2013-02-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
334 participants
INTERVENTIONAL
2006-01-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
NCT01586845
Special Access for the Use of Voclosporin for Kidney Transplantation
NCT01236287
A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
NCT00510913
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
NCT00895583
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
NCT01653847
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Dose Voclosporin
Low dose voclosporin
Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
Mid Dose Voclosporin
Mid Dose Voclosporin
Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
High Dose Voclosporin
High Dose Voclosporin
Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
Tacrolimus
Standard Dose Tacrolimus
tacrolimus
tacrolimus 0.05 mg/kg po BID
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Voclosporin
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
tacrolimus
tacrolimus 0.05 mg/kg po BID
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must be receiving a first cadaveric or living donor renal transplant.
* Patients must be able to receive oral medication at time of randomization.
* Females who are not pregnant or nursing or planning to become pregnant during the course of the study, or 3 months after last dose of study medication.
* Sexually-active women of child-bearing potential (including those who are \< 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.
* Able to give written informed consent prior to screening procedures.
* Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.
Exclusion Criteria
* Cold ischemic time \> 24 hours.
* Peak PRA (panel reactive antibodies) \> 30%
* Cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric donors positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Transplantation of multiple grafts (e.g. kidney and pancreas).
* Systemic infections requiring continued therapy at the time of entry into this study. (Prophylaxis against cytomegalovirus \[CMV\] and/or pneumocystis carinii pneumonia (PCP) infection will be permitted).
* Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus. Known negative serology prior to study entry may be used.
* A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
* Requires prohibited medications or treatment during the study.
* Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) ≥ 3x upper limit of normal (ULN) at time of transplantation.
* White blood cell count ≤ 2.8 x 10\^9/L.
* Triglycerides ≥ 3x ULN.
* Pregnant women or nursing mothers.
* Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to enrollment.
* Previous exposure to voclosporin.
* A history of active alcoholism or drug addiction within 1 year prior to study entry.
* Weighs \< 45 kg (99 lbs) or \> 140 kg (308 lbs).
* A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the investigator.
* Allergy to iodine.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aurinia Pharmaceuticals Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Abramowicz, MD, PhD
Role: STUDY_DIRECTOR
Erasme hospital
Philip Belitsky, MD
Role: STUDY_DIRECTOR
No Affiliation
Arthur Matas, MD
Role: STUDY_DIRECTOR
University of Minnesota
Mark Pescovitz, MD
Role: STUDY_DIRECTOR
Indiana University
A. Osama Gaber, MD
Role: STUDY_DIRECTOR
The Methodist Hospital Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Isotechnika Investigational Site
Birmingham, Alabama, United States
Isotechnika Investigational Site
Los Angeles, California, United States
Isotechnika Investigational Site
Los Angeles, California, United States
Isotechnika Investigational Site
Los Angeles, California, United States
Isotechnika Investigational Site
Orange, California, United States
Isotechnika Investigational Site
Palo Alto, California, United States
Isotechnika Investigational Site
San Diego, California, United States
Isotechnika Investigational Site
San Francisco, California, United States
Isotechnika Investigational Site
Denver, Colorado, United States
Isotechnika Investigational Site
Gainesville, Florida, United States
Isotechnika Investigational Site
Tampa, Florida, United States
Isotechnika Investigational Site
Chicago, Illinois, United States
Isotechnika Investigational Site
Chicago, Illinois, United States
Isotechnika Investigational Site
Lexington, Kentucky, United States
Isotechnika Investigational Site
New Orleans, Louisiana, United States
Isotechnika Investigational Site
New Orleans, Louisiana, United States
Isotechnika Investigational Site
Baltimore, Maryland, United States
Isotechnika Investigational Site
Boston, Massachusetts, United States
Isotechnika Investigational Site
Ann Arbor, Michigan, United States
Isotechnika Investigational Site
Detroit, Michigan, United States
Isotechnika Investigational Site
Rochester, Minnesota, United States
Isotechnika Investigational Site
Livingston, New Jersey, United States
Isotechnika Investigational Site
Buffalo, New York, United States
Isotechnika Investigational Site
Hawthorne, New York, United States
Isotechnika Investigational Site
New York, New York, United States
Isotechnika Investigational Site
Rochester, New York, United States
Isotechnika Investigational Site
Durham, North Carolina, United States
Isotechnika Investigational Site
Winston-Salem, North Carolina, United States
Isotechnika Investigational Site
Cincinnati, Ohio, United States
Isotechnika Investigational Site
Cincinnati, Ohio, United States
Isotechnika Investigational Site
Portland, Oregon, United States
Isotechnika Investigational Site
Portland, Oregon, United States
Isotechnika Investigational Site
Portland, Oregon, United States
Isotechnika Investigational Site
Philadelphia, Pennsylvania, United States
Isotechnika Investigational Site
Philadelphia, Pennsylvania, United States
Isotechnika Investigational Site
Charleston, South Carolina, United States
Isotechnika Investigational Site
Memphis, Tennessee, United States
Isotechnika Investigational Site
Dallas, Texas, United States
Isotechnika Investigational Site
Houston, Texas, United States
Isotechnika Investigational Site
Richmond, Virginia, United States
Isotechnika Investigational Site
Edmonton, Alberta, Canada
Isotechnika Investigational Site
London, Ontario, Canada
Isotechnika Investigational Site
Toronto, Ontario, Canada
Isotechnika Investigational Site
Montreal, Quebec, Canada
Isotechnika Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gregory CR, Kyles AE, Bernsteen L, Wagner GS, Tarantal AF, Christe KL, Brignolo L, Spinner A, Griffey SM, Paniagua RT, Hubble RW, Borie DC, Morris RE. Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model. Transplantation. 2004 Sep 15;78(5):681-5. doi: 10.1097/01.tp.0000131950.75697.71.
Stalder M, Birsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003 Dec;22(12):1343-52. doi: 10.1016/s1053-2498(03)00033-0.
Abel MD, Aspeslet LJ, Freitag DG, Naicker S, Trepanier DJ, Kneteman NM, Foster RT, Yatscoff RW. ISATX247: a novel calcineurin inhibitor. J Heart Lung Transplant. 2001 Feb;20(2):161. doi: 10.1016/s1053-2498(00)00290-4. No abstract available.
Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
Mayo PR, Ling SY, Huizinga RB, Freitag DG, Aspeslet LJ, Foster RT. Population PKPD of voclosporin in renal allograft patients. J Clin Pharmacol. 2014 May;54(5):537-45. doi: 10.1002/jcph.237. Epub 2013 Nov 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISA05-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.