Immunopharmacological Monitoring of Cyclosporin a-Treated Recipients of Cadaveric Kidney Allografts

Kahan, Barry D.; Buren, Charles T. Van; Lin, Shen Nan; Ono, Yoshinari; Agostino, Guy; LeGrue, Stephen J.; Boileau, Michel A.; Payne, William D.; Kerman, Ronald H.

doi:10.1097/00007890-198207000-00007

Cited by 87 publications

(14 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Initial data that the pharmacokinetic behavior of an immunosuppressive drug is important to predict outcome were first obtained with cyclosporine (CsA) (Kahan et al 1982(Kahan et al , 1983(Kahan et al , 1984. Almost 20 years of investigation have shown that concentration rather than dose determines outcome: A low drug exposure represents a risk factor for acute rejection episodes (Lindholm and Kahan 1993) and a variable exposure, a risk factor for chronic rejection .…”

Section: The University Of Texas Medical School At Houston Division mentioning

confidence: 99%

Abstracts of the NIH‐FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”

1998

Disease Markers

View full text Add to dashboard Cite

Abstracts of the NIH-FDA Conference 188 ForewordWelcome to the NIH-FDA Conference, "Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications". The current era of scientific discovery, including genomics, molecular medicine, and technological innovation, presents the research community with myriad prospective targets for developing powerful and effective therapies for many diseases and disorders. The prospect of an abundance of new therapies, however, poses new challenges to the scientific evaluation process that determines the efficacy and safety of these candidate therapies. Improving the efficiency of clinical trials is a critically important public health issue that all facets of the clinical trials enterprise must address to fully realize the potential for cures.The challenge to conference participants is to couple the growing understanding of pathogenesis with tools from the laboratory to develop more precise and accurate measures of disease in patients. The discovery of novel measures of biological factors, or biomarkers, that reflect the clinical response in disease offers the potential to streamline therapeutic development. Adaptation of these biomarkers as substitutes for clinical endpoints, or surrogate endpoints, in clinical trials has taken on new importance in light of the opportunities now before us. We hope this conference will chart a course of scientific discovery that unites the research community to achieve a common goal -enhancement of the abilities to measure disease and response to novel therapies in patients. Biomarkers and Surrogate Endpoints 189Plenary Session 1 Historical Perspectives Abstracts of the NIH-FDA Conference 190 Biomarkers as Surrogate Endpoints in Clinical Trials for HIV/AIDS: A Model for Other Diseases?Donna Mildvan, M.D. and Jonathan M. Kagan, Ph.D. Division of Infectious Diseases, Beth Israel Medical Center, and Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, USAIn the earliest days of the HIV/AIDS epidemic, the lack of sensitive biomarkers as near-term indicators of active therapy necessitated large clinical trials using mortality and AIDS progression as endpoints. This changed with the advent of molecular tools for the detection and quantitation of circulating HIV-1 RNA in all infected individuals. HIV-1 RNA and CD4 (the end organ for HIV attack) have been shown to predict clinical outcome in untreated patients and respond to active antiretroviral intervention. Together, these markers account for a significant proportion of the clinical benefit mediated by effective therapy. Collectively, these findings have permitted accelerated development and approval for HIV therapies, which have dramatically affected the epidemic in developed nations. However, despite these successes, these markers are incomplete in that they (1) only partially explain the clinical benefit of antiretroviral therapy; (2) have been observed to display discordant, hence uninterpretable, responses; and (3) have not been va...

show abstract

Section: The University Of Texas Medical School At Houston Division mentioning

confidence: 99%

Abstracts of the NIH‐FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”

1998

Disease Markers

View full text Add to dashboard Cite

show abstract

“…To sharpen the interrelationship between therapeutic effect and toxicity, pharmacologic (cyclosporin A blood and/or plasma levels) and immunologic monitoring were advocated by Keown (100), Rynasiewicz (101), and Kahan (102). Our techniques of management have not depended upon these monitoring techniques.…”

Section: >mentioning

confidence: 99%

Evolution of Liver Transplantation

et al. 1982

View full text Add to dashboard Cite

“…1,2 It was initially believed that monitoring Cmin (C 0 ) would be the most reproducible value accurately reflecting drug exposure, area under the time concentration curve (AUC), and the least likely to be affected by drug absorption and distribution phases. 3,4 While it is clear that AUC correlates well with freedom both from rejection and toxicity, C 0 does not correlate well with either exposure or clinical events. 5 The microemulsion formulation of CsA, Neoral, was developed to address some of the problems associated with the previous galenic formulation of CsA, Sandimmune.…”

mentioning

confidence: 98%

Neoral C₂ monitoring in maintenance liver transplant patients: A step forward?

Levy¹,

Cole²

2004

Liver Transpl

View full text Add to dashboard Cite

Immunopharmacological Monitoring of Cyclosporin a-Treated Recipients of Cadaveric Kidney Allografts

Cited by 87 publications

References 0 publications

Abstracts of the NIH‐FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”

Abstracts of the NIH‐FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”

Evolution of Liver Transplantation

Neoral C₂ monitoring in maintenance liver transplant patients: A step forward?

Contact Info

Product

Resources

About

Immunopharmacological Monitoring of Cyclosporin a-Treated Recipients of Cadaveric Kidney Allografts

Cited by 87 publications

References 0 publications

Abstracts of the NIH‐FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”

Abstracts of the NIH‐FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications”

Evolution of Liver Transplantation

Neoral C2 monitoring in maintenance liver transplant patients: A step forward?

Contact Info

Product

Resources

About

Neoral C₂ monitoring in maintenance liver transplant patients: A step forward?