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Cyclosporine C2 levels in de novo renal allograft recipients: a German multicenter prospective observational study.
Transplant Proc 2005; 37(3):1612-5TP

Abstract

This ongoing multicenter prospective observational study was undertaken in de novo renal allograft recipients managed with cyclosporine (CsA) trough (C0) and 2-hour postdose (C2) level monitoring at defined times so as to assess the risk for an acute rejection episode or allograft dysfunction. The renal transplant recipients (n = 159) were enrolled at 11 German centers. The 6-month posttransplant data from 138 patients were evaluable for this interim analysis. Mean C2 levels (ng/mL), which were measured by liquid chromatography-tandem mass spectrometry at a central laboratory, were: days 3 to 5: 873.1 +/- 391.9; days 7 to 10: 939.1 +/- 422.8; days 14 to 28: 1116.3 +/- 497.6; 3 months: 905.0 +/- 316.8; and after 6 months: 787.0 +/- 276.5. To identify patients at higher risk for acute rejection or allograft dysfunction, we calculated the relative CsA absorption capacity (C2 [ng/mL]/morning dose [mg/kg]; CsA-Abs), yielding mean values on days 3 to 5: 284.4 +/- 115.1; days 7 to 10: 306.7 +/- 134.8; days 14 to 28: 382.5 +/- 164.7; month 3: 501.5 +/- 168.8; month 6: 512.7 +/- 176.5. Three groups were distinguished by CsA-Abs at days 7 to 10: low absorbers (CsA-Abs < 200), normal absorbers (CsA-Abs 200 to 350), and high absorbers (CsA-Abs > 350). A between-group comparison of absorption level at 6 months posttransplant revealed the incidences of biopsy-proven acute rejection and Cockcroft-Gault formula-based mean glomerular filtration rates of 23.8% and 54.7 +/- 19.0 mL/min, 22.6% and 59.5 +/- 20.7 mL/min, and 17.6% and 67.7 +/- 23.5, respectively. In conclusion, mean C2 levels >1000 ng/mL are attained within 2 to 4 weeks, with CsA-Abs increasing continuously over the first 6 posttransplant months. High CsA absorbers show a propensity toward good allograft function and lower acute rejection rates at 6 months after renal transplantation.

Authors+Show Affiliations

Transplant Center, Kliniken der Stadt Koeln, Koeln, Germany. wolfgang.arns@uni-koeln.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15866687

Citation

Arns, W, et al. "Cyclosporine C2 Levels in De Novo Renal Allograft Recipients: a German Multicenter Prospective Observational Study." Transplantation Proceedings, vol. 37, no. 3, 2005, pp. 1612-5.
Arns W, Zantvoort F, Abendroth D, et al. Cyclosporine C2 levels in de novo renal allograft recipients: a German multicenter prospective observational study. Transplant Proc. 2005;37(3):1612-5.
Arns, W., Zantvoort, F., Abendroth, D., Seiter, H., Scheuermann, E. H., Albert, U., ... Ulbricht, B. (2005). Cyclosporine C2 levels in de novo renal allograft recipients: a German multicenter prospective observational study. Transplantation Proceedings, 37(3), pp. 1612-5.
Arns W, et al. Cyclosporine C2 Levels in De Novo Renal Allograft Recipients: a German Multicenter Prospective Observational Study. Transplant Proc. 2005;37(3):1612-5. PubMed PMID: 15866687.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cyclosporine C2 levels in de novo renal allograft recipients: a German multicenter prospective observational study. AU - Arns,W, AU - Zantvoort,F, AU - Abendroth,D, AU - Seiter,H, AU - Scheuermann,E-H, AU - Albert,U, AU - Stahl,R, AU - Fornara,P, AU - Fricke,L, AU - Neumayer,H H, AU - Nagel,E, AU - Michel,U, AU - Ulbricht,B, PY - 2005/5/4/pubmed PY - 2005/9/27/medline PY - 2005/5/4/entrez SP - 1612 EP - 5 JF - Transplantation proceedings JO - Transplant. Proc. VL - 37 IS - 3 N2 - This ongoing multicenter prospective observational study was undertaken in de novo renal allograft recipients managed with cyclosporine (CsA) trough (C0) and 2-hour postdose (C2) level monitoring at defined times so as to assess the risk for an acute rejection episode or allograft dysfunction. The renal transplant recipients (n = 159) were enrolled at 11 German centers. The 6-month posttransplant data from 138 patients were evaluable for this interim analysis. Mean C2 levels (ng/mL), which were measured by liquid chromatography-tandem mass spectrometry at a central laboratory, were: days 3 to 5: 873.1 +/- 391.9; days 7 to 10: 939.1 +/- 422.8; days 14 to 28: 1116.3 +/- 497.6; 3 months: 905.0 +/- 316.8; and after 6 months: 787.0 +/- 276.5. To identify patients at higher risk for acute rejection or allograft dysfunction, we calculated the relative CsA absorption capacity (C2 [ng/mL]/morning dose [mg/kg]; CsA-Abs), yielding mean values on days 3 to 5: 284.4 +/- 115.1; days 7 to 10: 306.7 +/- 134.8; days 14 to 28: 382.5 +/- 164.7; month 3: 501.5 +/- 168.8; month 6: 512.7 +/- 176.5. Three groups were distinguished by CsA-Abs at days 7 to 10: low absorbers (CsA-Abs < 200), normal absorbers (CsA-Abs 200 to 350), and high absorbers (CsA-Abs > 350). A between-group comparison of absorption level at 6 months posttransplant revealed the incidences of biopsy-proven acute rejection and Cockcroft-Gault formula-based mean glomerular filtration rates of 23.8% and 54.7 +/- 19.0 mL/min, 22.6% and 59.5 +/- 20.7 mL/min, and 17.6% and 67.7 +/- 23.5, respectively. In conclusion, mean C2 levels >1000 ng/mL are attained within 2 to 4 weeks, with CsA-Abs increasing continuously over the first 6 posttransplant months. High CsA absorbers show a propensity toward good allograft function and lower acute rejection rates at 6 months after renal transplantation. SN - 0041-1345 UR - https://www.unboundmedicine.com/medline/citation/15866687/Cyclosporine_C2_levels_in_de_novo_renal_allograft_recipients:_a_German_multicenter_prospective_observational_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0041-1345(04)01088-7 DB - PRIME DP - Unbound Medicine ER -