Navigation Links
Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy
Date:5/31/2009

The results of these studies will be presented during the American Transplant Congress in Boston, MA May 30 - June 3, 2009

COLUMBIA, Md., May 31 /PRNewswire/ -- The results of two large studies presented by researchers from the Starzl Transplant Institute at the University of Pittsburgh Medical Center demonstrated the long-term safety and efficacy of alemtuzumab induction and tacrolimus monotherapy.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090424/NE99362LOGO )

Led by Dr. Henkie Tan, this group performed 200 consecutive living donor kidney transplants using a regimen of alemtuzumab pre-conditioning and tacrolimus monotherapy with subsequent weaning. Beginning at 6 months posttransplant and at 2-6 month intervals, they used a battery of clinical data including ELISA antibody titers, donor-specific antibodies and the ImmuKnow(R) assay to wean tacrolimus whenever possible. Patients were followed in this manner for an average of 50.0 (+/-11.6) months.

Actuarial recipient survival after 1, 2, 3, 4, and 5 years were 99.0%, 96.5%, 94.4%, 92.0% and 87.1%, respectively. Graft survivals at the same time points were 98.0%, 90.5%, 87.5%, 80.1%, and 73.7%, respectively. The mean (+/-SD) creatinine (mg/dL) after 1, 2, 3, and 4 years were 1.43 (+/-0.55), 1.58 (+/-1.13), 1.51 (+/-0.89), and 1.55 (+/-1.46), respectively. The mean (+/-SD) GFR (mL/min/1.73m(2)) at these time points were 58.7 (+/-21.6), 55.1 (+/-21.4), 55.3 (+/-21.1), and 57.6 (+/-24.6), respectively. The cumulative incidence of acute cellular rejection (ACR) at 1, 3, 6, 12, 18, 24, 30, 36, 42, and 48 months were 1.0%, 1.0%, 2.0%, 9.0%, 16.5%, 19.5%, 24.0%, 24.5%, 28.0%, and 28.5%, respectively. Most recipients (77.0%) were weaned to every-other-day or less dosing of tacrolimus monotherapy. Among 60 recipients with ACR, the incidence of pre-weaning ACR was 8.5% and post-weaning ACR was 27.9%. At this time, >/= 90% of recipients remain steroid-free on tacrolimus monotherapy.

In a similar study report, Dr. Tan and colleagues performed 478 consecutive unselected living donor kidney transplants using alemtuzumab pre-conditioning and tacrolimus monotherapy. Once again, they used a series of clinical tests including ELISA antibody titers, donor-specific antibodies and the ImmuKnow assay beginning 6 months posttransplant and at 2-6 months intervals. Using these data, tacrolimus was weaned whenever possible. These patients were followed for an average of 35.6 (+/-19.7) months.

Recipient survivals at 1, 2, 3, and 4 years were 98.4%, 95.3%, 93.3%, and 90.4%, respectively. Graft survivals at the same time points were 97.1%, 89.6%, 85.2%, and 77.5%, respectively. The mean (+/-SD) creatinine (mg/dL) after 1, 2 and 3 years were 1.42 (+/-0.61), 1.56 (+/-0.96) and 1.53 (+/-0.83), respectively. The mean (+/-SD) GFR (mL/min/1.73m(2)) at these time points were 59.2 (+/-23.6), 55.0 (+/-21.7) and 53.9 (+/-21.7), respectively. The cumulative incidence of ACR after 1, 3, 6, 12, 18, 24, 30, and 36 months were 1.9%, 3.1%, 4.2%, 9.2%, 14.0%, 16.3%, 18.8% and 19.5%, respectively.

Weaning to every-other-day or less dosing of tacrolimus monotherapy was attempted in 41% of patients. Among 397 patients with functional grafts, 82 (20.6%) are on spaced-dose tacrolimus monotherapy. A total of 114 recipients had ACR. The incidence of pre-weaning ACR was 11.7% and post-weaning was 30.1%. At this time, >/= 80.6% of recipients remain steroid-free on tacrolimus monotherapy.

The use of the ImmuKnow assay as described in these studies has not been cleared by the U.S. Food & Drug Administration.

About ImmuKnow

ImmuKnow is a noninvasive biomarker of immune function that assesses cellular immune status by detecting cell-mediated immunity (CMI) in adult immunosuppressed patients. It measures the concentration of adenosine triphosphate (ATP) released from CD4 cells following cell stimulation. The ImmuKnow test is a qualitative assay and does not directly quantify the level of immunosuppression. Results of the ImmuKnow assay should be used in conjunction with clinical presentation, medical history, and other clinical indicators when assessing the immune status of any individual patient.

About Cylex, Inc.

Cylex is a privately held global life sciences company that is the leader in the development and manufacture of in vitro diagnostic products that are intended to illuminate immunity. ImmuKnow is the in vitro diagnostic utilized to detect cell-mediated immunity (CMI) in an immunosuppressed population, and is increasingly being adopted at organ transplant centers throughout the United States and abroad. The Company's patented technology provides an innovative platform allowing clinicians to simply and reproducibly assess CMI. The Company is based in Columbia, MD USA. http://www.cylex.net


'/>"/>
SOURCE Cylex, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Shows Lantus(R) Helped People Living with Type 2 Diabetes Reach the ADAs Recommended Target for Blood Sugar Control
2. Study Confirms That Avastin Significantly Increases Chance of Living Without Disease Progression in Metastatic Breast Cancer
3. Mayo Clinic Proceedings Contributors Discuss Impact of Donor Organ Allocation System
4. Organ Donor Shortage Remains Obstacle for Would-Be Transplant Patients Despite Better Medicine
5. AUA Guideline: Full Kidney Removal Not Necessary for All Kidney Tumors
6. Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib
7. Medgenics Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients
8. DaVita Abstracts Accepted Into National Kidney Foundations 2009 Spring Symposium
9. Freezing Kidney Cancer: Hot Treatment Should Be New Gold Standard for Destroying Small Tumors
10. Medgenics Announces Positive Data From Phase I/II Clinical Trial of EPODURE Treatment of Anemia in Chronic Kidney Disease
11. Latest RAD001 Study Results Show Further Increase in Time Without Tumor Growth in Patients With Advanced Kidney Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... 2017  Ethicon Endo-Surgery, Inc. announced today ... Inc., a privately held medical device company ... used in operating rooms worldwide. The acquisition ... energy devices with Megadyne,s innovative portfolio of ... in Ethicon,s goal to deliver the most ...
(Date:1/20/2017)... DUBAI , VAE, January 20, 2017 ... den stark gestiegenen Bedarf an Nothilfe   Die ... um Platz für Hilfsgüter zu schaffen   ... Vizepräsident und Premierminister der VAE sowie Herrscher von ... Umfang der internationalen Stadt der Hilfe (International Humanitarian City ...
(Date:1/19/2017)... Jan. 19, 2017 The Global Therapy Partnering ... access to partnering deals and agreements entered into by ... partnering deals - Top deals by value - Deals ... technology type The report provides understanding and access ... the world,s leading healthcare companies. The report provides ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... , ... Michael and Betsy Brauser celebrated 5 years of Betsy’s participation in ... has been life-saving as she has been on the trial for more than ... with ovarian cancer in 2009. She underwent standard chemotherapy but a year later went ...
(Date:1/20/2017)... ... 2017 , ... “Mary Magdalene: Grace is Greater than Sin”: a unique ... Jesus Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” is the creation of ... interacting with countless women who had little knowledge of the female characters portrayed in ...
(Date:1/20/2017)... ... ... a fine examination of how God handles sin, including how to let go of lingering ... for over ten long years has been waiting to release this powerful insight about forgiveness ... been serving the Lord for over twenty years, and he has been preaching and teaching ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “Journey to Christmas:” a beautiful and enchanting ... of published author, Kimberly Cordoves, a mother of three in Oklahoma City, and a devoted ... idea of writing a book has been in the back of my mind for years, ...
(Date:1/20/2017)... ... January 20, 2017 , ... “God's Miracle Man: Against ... Odds” is the creation of published author, Keith C. A. Tucker, son of Minister ... Fellowship World Outreach pastured by Reverend Mark Hardy , “While sitting up in bed, ...
Breaking Medicine News(10 mins):