Tags

Type your tag names separated by a space and hit enter

Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion.
Transplantation 2003; 76(6):903-8T

Abstract

BACKGROUND

MO2ART (monitoring of 2-hr absorption in renal transplantation) is the first prospective, multicenter trial of cyclosporine (CsA) blood level 2 hr postdose (C2) monitoring in de novo kidney recipients receiving CsA microemulsion (ME) (Neoral; Novartis, Basel, Switzerland). Efficacy and safety results from the first 3 months are presented here.

METHODS

MO2ART is a 12-month, open-label, randomized study involving 296 patients. In all patients, the dose of CsA-ME was adjusted to achieve protocol-defined C2 targets of 1.6 to 2.0 microg/mL for the first month, with subsequent tapering. Randomization into two target groups occurred at 3 months. All patients received steroids and mycophenolate mofetil (89%) or azathioprine. For patients with delayed graft function, the protocol permitted reduced C2 targets and prophylactic administration of antibodies.

RESULTS

At 3 months, overall incidence of biopsy-proven acute rejection was 11.5%. Median serum creatinine was 132 micromol/L. Patient and graft survival were 96.6% and 91.2%, respectively. C2 levels greater than 1.6 microg/mL were achieved within 5 days by 60.6% of patients with immediate graft function and 19.5% of patients with delayed graft function. Prophylactic antibodies were used in 15% of the total population. Twenty-four patients (8.1%) experienced serious adverse events with a suspected relation to CsA, and 26 patients (8.8%) discontinued the study because of adverse events (n=15) or after a switch in immunosuppression after rejection episodes (n=11).

CONCLUSIONS

Patient management by C2 monitoring resulted in a low incidence of biopsy-proven acute rejection in standard risk de novo kidney recipients, 85% of whom did not receive prophylactic antibodies. CsA-ME with C2 monitoring provides excellent short-term efficacy and safety among de novo renal transplant patients.

Authors+Show Affiliations

Service de Nephrologie et Transplantation Renale, Hôpital St Louis, Paris, France. eric.thervet@sls.ap-hop-paris.fr

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14508352

Citation

Thervet, Eric, et al. "Clinical Outcomes During the First Three Months Posttransplant in Renal Allograft Recipients Managed By C2 Monitoring of Cyclosporine Microemulsion." Transplantation, vol. 76, no. 6, 2003, pp. 903-8.
Thervet E, Pfeffer P, Scolari MP, et al. Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion. Transplantation. 2003;76(6):903-8.
Thervet, E., Pfeffer, P., Scolari, M. P., Toselli, L., Pallardó, L. M., Chadban, S., ... Cole, E. (2003). Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion. Transplantation, 76(6), pp. 903-8.
Thervet E, et al. Clinical Outcomes During the First Three Months Posttransplant in Renal Allograft Recipients Managed By C2 Monitoring of Cyclosporine Microemulsion. Transplantation. 2003 Sep 27;76(6):903-8. PubMed PMID: 14508352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical outcomes during the first three months posttransplant in renal allograft recipients managed by C2 monitoring of cyclosporine microemulsion. AU - Thervet,Eric, AU - Pfeffer,Per, AU - Scolari,Maria Piera, AU - Toselli,Lorenzo, AU - Pallardó,Luis M, AU - Chadban,Steven, AU - Pilmore,Helen, AU - Connolly,John, AU - Buchler,Matthias, AU - Schena,Francesco Paolo, AU - Carreño,César Agost, AU - Dandavino,Raymond, AU - Cole,Edward, PY - 2003/9/26/pubmed PY - 2003/10/24/medline PY - 2003/9/26/entrez SP - 903 EP - 8 JF - Transplantation JO - Transplantation VL - 76 IS - 6 N2 - BACKGROUND: MO2ART (monitoring of 2-hr absorption in renal transplantation) is the first prospective, multicenter trial of cyclosporine (CsA) blood level 2 hr postdose (C2) monitoring in de novo kidney recipients receiving CsA microemulsion (ME) (Neoral; Novartis, Basel, Switzerland). Efficacy and safety results from the first 3 months are presented here. METHODS: MO2ART is a 12-month, open-label, randomized study involving 296 patients. In all patients, the dose of CsA-ME was adjusted to achieve protocol-defined C2 targets of 1.6 to 2.0 microg/mL for the first month, with subsequent tapering. Randomization into two target groups occurred at 3 months. All patients received steroids and mycophenolate mofetil (89%) or azathioprine. For patients with delayed graft function, the protocol permitted reduced C2 targets and prophylactic administration of antibodies. RESULTS: At 3 months, overall incidence of biopsy-proven acute rejection was 11.5%. Median serum creatinine was 132 micromol/L. Patient and graft survival were 96.6% and 91.2%, respectively. C2 levels greater than 1.6 microg/mL were achieved within 5 days by 60.6% of patients with immediate graft function and 19.5% of patients with delayed graft function. Prophylactic antibodies were used in 15% of the total population. Twenty-four patients (8.1%) experienced serious adverse events with a suspected relation to CsA, and 26 patients (8.8%) discontinued the study because of adverse events (n=15) or after a switch in immunosuppression after rejection episodes (n=11). CONCLUSIONS: Patient management by C2 monitoring resulted in a low incidence of biopsy-proven acute rejection in standard risk de novo kidney recipients, 85% of whom did not receive prophylactic antibodies. CsA-ME with C2 monitoring provides excellent short-term efficacy and safety among de novo renal transplant patients. SN - 0041-1337 UR - https://www.unboundmedicine.com/medline/citation/14508352/Clinical_outcomes_during_the_first_three_months_posttransplant_in_renal_allograft_recipients_managed_by_C2_monitoring_of_cyclosporine_microemulsion_ L2 - http://Insights.ovid.com/pubmed?pmid=14508352 DB - PRIME DP - Unbound Medicine ER -