Single-center study utilizing C2 level as monitoring tool in de novo renal transplant recipients treated with neoral

Keshavamurthy, Mohan; Ahmadi, Iraj; Raza, S; Baynton, R.; Meshari, Khalid Al; Shaibani, Khaled Al

doi:10.1016/s0041-1345(01)02327-2

Cited by 11 publications

(7 citation statements)

References 6 publications

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“…Management of transplanted adults by cyclosporin (CsA) monitoring according to drug levels at 2-h (C2) post-dose improved clinical outcome when compared with conventional trough level monitoring (1). Several clinical trails in kidney and liver transplant recipients confirm these findings (2)(3)(4)(5)(6)(7)(8). Target values for C2 monitoring in adult kidney transplant recipients have been established for different time points after transplantation (9,10).…”

mentioning

confidence: 96%

Cyclosporin A monitoring by 2‐h levels: preliminary target levels in stable pediatric kidney transplant recipients

Pape

Lehnhardt

Latta

et al. 2003

Clinical Transplantation

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Clinical trials in adults have shown that management of transplanted patients with cyclosporin A (CsA) 2-h levels (C2) lead to superior outcome compared with monitoring of 12-h trough levels (C0). In both adults and children, C2 levels enabled a better estimation of the area under the curve concentration than C0 levels. Therefore, it can be suspected that C2 monitoring might also lead to a better outcome in children. Until now C2 target levels for children have not been defined. We measured C2 levels in 101 stable pediatric kidney recipients with a minimum time of 1 yr after transplantation. C2 levels were compared with changes in glomerular filtration rate (GFR) 6 months later. Median C2 levels in children after renal transplantation were 714 ng/mL (95% confidence interval 654-774). Patients with C2 levels below 750 ng/mL had a significantly higher percentage of decline in GFR than patients with C2 levels above 750 ng/mL (p< 0.05). In children with C2 levels below 500 ng/mL three acute rejections occurred in comparison with no rejection in the remaining patients (p < 0.05). We conclude that the lower C2 target level should be above 750 ng/mL in stable pediatric transplant recipients. An upper target level above 1000 ng/mL should be avoided. The question, whether C2 monitoring in pediatric kidney recipients is superior to C0 monitoring, is yet to be answered.

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confidence: 96%

Cyclosporin A monitoring by 2‐h levels: preliminary target levels in stable pediatric kidney transplant recipients

Pape

Lehnhardt

Latta

et al. 2003

Clinical Transplantation

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“…It is a common practice to measure the trough levels of cyclosporine (C0) rather than the peak (C-2) because of more consistent timing. However, extensive research on using C-2 values to monitor patients receiving cyclosporine has demonstrated reduced incidence and severity of rejection in de novo patients 45. Although many acknowledge the advantage of area-under-the-curve (AUC) monitoring, it has failed to gain widespread acceptance because of the practical difficulties in AUC measurement, both for the patient and the clinician.…”

Section: Discussionmentioning

confidence: 99%

Utility of C-2 (Cyclosporine) monitoring in postrenal transplant patients: A study in the Indian population

Thakur¹,

Kumar²,

Gupta³

2008

Indian J Nephrol

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The study was planned and conducted to assess the benefit of C-2 levels (blood cyclosporine levels two hours postdosing) monitoring over trough (C0) levels (predosing) in postrenal transplant patients. The patient population included 34 postrenal transplant individuals (28 males and six females, mean age of 39.9 ± 12.3 years). The patients were first-transplant patients and were receiving a microemulsion form of cyclosporine A (CsA) as an immunosuppressant along with azathioprine and prednisolone. In addition, they were not on any enzyme inducer/inhibitor drugs, except for diltiazem. Timed collection of C0 and C-2 samples was done and the samples were immediately processed using the cedia cyclosporine plus assay kit. Estimation was done on a Beckman synchron CX5CE fully automated chemistry analyzer. Serum urea nitrogen and creatinine levels were checked. Poor graft survival was found in this population with 29.3% patients showing graft rejection. The graft rejection patients were assigned to two groups: group I with chronic graft rejection patients (17.6%) and group II with acute graft rejection patients (11.7%). Group III consisted of graft survival patients (70.7%). Mean ± SD was calculated for C0 and C2 levels. Individual values for C0 and C-2 were plotted on a scatter chart. C0 and C-2 levels were normalized by calculating them as the percentage of their targets (data not shown) and compared using the Kruskal Wallis one-way analysis of variance. C0 levels in all the three groups were within the recommended therapeutic range (150–300 ng/mL) (P < 0.182). Blood C-2 concentrations did not achieve the recommended target levels in these patients. One-way analysis of variance for C-2 values when expressed as the percentage of the target values did not show any significant difference between these groups (P < 0.84). No significant difference was found in C0 levels between groups I, II, and group III patients when expressed as the percentage of the target values (P < 0.182). The mean serum urea nitrogen level was 26.4 ± 8.1 mg/dL whereas the mean serum creatinine level was 1.79 ± 0.8 mg/dL. As is evident in the present study, the target C2 levels of cyclosporine dosage were not achieved whereas the C0 levels in all the three groups were within the optimum therapeutic range. As the incidence of graft dysfunction was also proportionately high, the importance of C2 monitoring is further highlighted on the basis of this study The contributory factors for levels lower than the target levels, such as the use of low doses of cyclosporine and interacting drugs should be carefully monitored in clinical practice. The achievement of optimum levels of C-2 may help in reducing the higher incidence of graft rejection in these patients. This practice is of equal importance in reducing cyclosporine-related renal toxicity, a rather irreversible process.

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“…They reported that the 2‐h postdose sampling point (C2) was the most accurate single‐point marker in various transplanted organs, including heart [5,9–12]. Recent clinical trials indicate positive correlation of C2 levels with probability of freedom from acute rejection in de novo renal and liver transplants [6,13–17]. In addition, initial data suggest correlation of C2, but not of C0, with chronic rejection, as well as beneficial effects on renal function, in long‐term renal and liver transplants, switched to C2 monitoring [7,18–20].…”

Section: Introductionmentioning

confidence: 99%

C2 is superior to C0 as predictor of renal toxicity and rejection risk profile in stable heart transplant recipients

Caforio¹,

Tona²,

Piaserico³

et al. 2005

Transplant Int

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Summary To assess whether cyclosporine A (CsA) 2‐h peak (C2) is superior to trough levels (C0) for Neoral dose monitoring in heart transplantation (HT), we studied 928 C0–C2 paired determinations from 313 stable HT patients (257 male, aged 50 ± 14 years at HT, follow‐up 6.9 ± 4 years), on a C0‐based regimen. Our target C0 levels (ng/ml) were 150–400 (first 3 months), 150–300 (4–12 months), 100–250 (>12 months). Mean C0 and C2 levels were 268 ± 80 and 1031 ± 386, respectively (first 3 months); 230 ± 49 and 955 ± 239 (4–12 months); 157 ± 53 and 745 ± 236 (>12 months). For patients within the target C0, the corresponding C2 were 600–1500 (first 3 months), 600–1300 (4–12 months), 400–1100 (>12 months). C2 correlated with C0 (r = 0.64, P = 0.0001). C2 correlated better with CsA dose than C0 (r = 0.41, P = 0.0001 vs. r = 0.33, P = 0.0001). Between patients, CsA dose varied by a factor of 9.3; the C/dose ratio varied by a factor of 8.5 for C2 and of 15.6 for C0. Patients with higher C2 (>740) had higher severe rejection score at 2 years (P = 0.02) than patients with lower C2. This did not apply to C0. Both C2 and C0 correlated with blood urea (r = −0.18, P = 0.0001; r = −0.12, P = 0.0002) and creatinine (r = −0.19, P = 0.0004; r = −0.19, P = 0.0001 respectively). By logistic regression higher C2 (>740) was associated with higher total severe rejection score at 2 years (P = 0.006). C2 showed better correlation with CsA dose, renal function, rejection profile and less variability between patients than C0. C2 may improve CsA‐based immunosuppression in HT.

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Single-center study utilizing C2 level as monitoring tool in de novo renal transplant recipients treated with neoral

Cited by 11 publications

References 6 publications

Cyclosporin A monitoring by 2‐h levels: preliminary target levels in stable pediatric kidney transplant recipients

Cyclosporin A monitoring by 2‐h levels: preliminary target levels in stable pediatric kidney transplant recipients

Utility of C-2 (Cyclosporine) monitoring in postrenal transplant patients: A study in the Indian population

C2 is superior to C0 as predictor of renal toxicity and rejection risk profile in stable heart transplant recipients

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