Mycophenolate as maintenance therapy for lupus nephritis with impaired renal function.

BACKGROUND: Mycophenolate (MF) is effective as a maintenance therapy after induction therapy in patients with lupus nephritis (LN). However, little is known about its role in patients with impaired renal function. The purpose of this study was to evaluate the efficacy and safety of MF as a maintenance therapy for LN and its association with renal function. METHODS: Data were obtained for 56 Spanish patients who were receiving MF as a maintenance therapy for LN. Patients were classified into two groups according to renal function at the initiation of MF treatment: group 1 [estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73 m(2)] and group 2 (eGFR <60 ml/min/1.73 m(2)). The primary endpoints of the study were the rates of renal relapse and responses, and their relationship with baseline renal function. Secondary outcomes were the appearance of side effects during treatment. RESULTS: At initiation of MF treatment, the only differences between the groups were for age, hemoglobin levels, anti-DNA antibody titer, proteinuria, and renal function. In group 1 (n = 38), the eGFR was 98 ± 34 ml/min/1.73 m(2) and in group 2 (n = 18) the eGFR was 43 ± 14 ml/min/1.73 m(2). Only 3 cases had an eGFR <30 ml/min/1.73 m(2). No significant differences were observed in the rate of relapse at 6 months (group 1: 20%; group 2: 23%) or at 12 months (group 1: 25%; group 2: 17%). Response rates were also similar in both groups. Side effects were unremarkable. CONCLUSIONS: MF is effective and safe as a maintenance therapy for LN both in patients with normal renal function and in those with renal impairment.

Concordance of estimated glomerular filtration rates using Cockcroft-Gault modification of diet in renal disease, and chronic kidney disease epidemiology in renal transplant recipients.

INTRODUCTION: Various equations have been used to estimate the glomerular filtration rate (GFR) in renal patients, including kidney transplant recipients. Controversy exists concerning which equation is more precise to determine kidney failure. AIM: The aim of this study was to analyze the concordance (bias, variability, and exactness) of GFR estimated by the Modification of Diet in Renal Disease (MDRD4) and the Chronic Kidney Disease Epidemiology (CKD-EPI) equations using the Cockcroft-Gault (CG) method as the reference. MATERIAL AND METHODS: This observational, cross-sectional study included 153 clinically stable patients who underwent kidney transplantation between 2007 and 2009. The GFR was estimated at 12 months after the transplantation using the MDRD and CKP-EPI formula, using CG as the reference. RESULTS: The mean GFR for the various methods was as follows: CG = 65.6 ± 23.3 mL/min/1.73 m(2), MDRD4 = 54.9 ± 19.3 mL/min/1.73 m(2), and CKD-EPI = 55.8 ± 19.6 mL/min/1.73 m(2). Good correlations were found between CG-MDRD4 (r = 0.84; P < .001), CG-CKD-EPI (r = 0.87; P < .001), and MDRD4-CKD-EPI (r = 0.98; P < .001). The analysis of concordance detected a bias (normal difference) of -10.6 ± 12.7 versus -9.8 ± 11.3 mL/min/1.73 m(2) (P = .006), a variability (percent difference) of 14.5 ± 15.4% versus 13.6 ± 14.5% (P = .031), and an exactness (P30) of 81.7% versus 86.9% (P < .001) of CG-MDRD4 versus CG-CKD-EPI, respectively. For a GFR >60 mL/min/1.73 m(2) the exactness was 75.3% versus 83.5% (P < .001) for CG-MDRD4 versus CG-CKD-EPI, and for a GFR ≤ 60 mL/min/1.73 m(2) it was 89.7% versus 91.2% (P < .001). CONCLUSIONS: In our population the CKD-EPI method most approached the CG values, particularly when the GFR was >60 mL/min/1.73 m(2).

Mycophenolate as induction therapy in lupus nephritis with renal function impairment.

BACKGROUND: Mycophenolate (MF) is effective as induction therapy for lupus nephritis (LN) in patients with normal renal function; however, little is known about its role in patients with impaired renal failure. The purpose of this study was to evaluate the response to MF in LN and its association with baseline renal function. METHODS: Data were obtained for 90 patients from 12 Spanish renal units who were receiving MF as induction therapy for LN. Patients were classified into 2 groups: group 1 (estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73 m(2)) and group 2 (eGFR <60 ml/min/ 1.73 m(2)). The primary outcome measure was the percentage of patients who achieved any response and its relationship with initial eGFR. The secondary outcome measures were the percentage of patients who achieved a complete response (CR) or partial response (PR) and the appearance of relapses during treatment and side effects. RESULTS: At initiation of MF treatment, there were no differences in the main parameters between group 1 (n = 63; eGFR 87 ± 23 ml/min/ 1.73 m(2)) and group 2 (n = 27; eGFR 44 ± 12 ml/min/1.73 m(2)). Exposure to prednisone and MF was similar. The percentages of patients who achieved a response in groups 1 and 2 were, respectively, 69.2 and 43.8% at 6 months and 81.3 and 73.7% at 12 months. CR was more frequent in group 1, whereas PR was similar in both groups. Four patients relapsed and side effects were unremarkable. CONCLUSIONS: MF is effective and safe as induction therapy for LN, and response is even achieved in patients with baseline renal impairment.