Mycophenolate mofetil versus cyclophosphamide for idiopathic membranous nephropathy; a double blind and randomized clinical trial

Introduction: The current treatment regimens for patients with idiopathic membranous nephropathy (MN) are based on cyclophosphamide-glucocorticoid or calcineurin inhibitor-glucocorticoid. Objectives: We evaluated whether mycophenolate mofetil (MMF) -glucocorticoid could be an option for first-line therapy among these patients. Patients and Methods: In a double-blinded, randomized and controlled clinical trial, we compared the effect of MMF with cyclophosphamide in inducing complete or partial remission (PR) among patients with nephrotic syndrome due to idiopathic MN. All of the patients in both groups also received steroid, renin-angiotensin blockers and statins. Diuretics were also used in the patients who had edema. The primary end point of our study was change in urinary protein/creatinine ratio. Results: A total of 30 patients completed the study. Around 17 patients received MMF (2 g/d) and 13 patients received intravenous or oral cyclophosphamide for 6 months. At the start of the study, no significant differences in demographic and biochemical parameters of patients including the urinary protein excretion rate between two groups (P = 0.432). The proportion of proteinuria was 5235 ± 1655 mg/24 in MMF group and 8781 ± 8741 mg/24 in the cyclophosphamide group at the beginning of the study. The rate of complete and PR were 5.9% and 52.9 in MMF group versus 16.7% and 100% in cyclophosphamide group which it is significantly lower in MMF group. Kidney function was stable in both groups during treatment. Conclusions: According to the result of our study, a 6-month therapy with MMF-glucocorticoid is not recommended for treatment of patients with nephrotic syndrome due to idiopathic MN.

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Faculty of 1000 evaluation for Efficacy and Safety of Traditional Chinese Medicine (Shenqi Particle) for Patients With Idiopathic Membranous Nephropathy: A Multicenter Randomized Controlled Clinical Trial.

F1000 - Post-publication peer review of the biomedical literature ◽

10.3410/f.718025278.793484562 ◽

2013 ◽

Author(s):

Jeremy Chapman ◽

Angela Webster

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Membranous Nephropathy ◽

Idiopathic Membranous Nephropathy ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled

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Risk of Adverse Events Is Similar in Patients (Pts) Who Did or Did Not Achieve Hemoglobin (Hb) Above 12g/dL in a Phase 3 Clinical Trial of Darbepoetin alfa (DA) Administered Weekly (QW) or Every 3 Weeks (Q3W) in Anemic Cancer Pts Receiving Chemotherapy.

Blood ◽

10.1182/blood.v110.11.4086.4086 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4086-4086

Author(s):

Heinz Ludwig ◽

Jean-Luc Canon ◽

Johan Vansteenkiste ◽

Lisa Hamilton ◽

Tamás Suto

Keyword(s):

Myocardial Infarction ◽

Clinical Trial ◽

Adverse Events ◽

Dose Group ◽

Exposure Period ◽

Current Treatment ◽

Comparable Efficacy ◽

Controlled Clinical Trial ◽

Double Blind ◽

The Impact

Abstract Until now data on the frequency of adverse events (AEs) at different Hb levels have been lacking; these could help to define the impact of using different therapeutic Hb thresholds for erythropoiesis-stimulating agents. To evaluate the impact of when Hb >12g/dL, we evaluated data from a double-blind, randomized, active-controlled clinical trial of DA in anemic cancer pts (Hb <11g/dL) receiving chemotherapy (Canon, JNCI2006;98:373), the most recently conducted trial reflecting approved DA doses (2.25mcg/kg QW and 500mcg Q3W) and current treatment practices in Europe. Methods: This posthoc analysis evaluates transfusion (TFN) and AE data in pts who did or did not achieve Hb >12g/dL during the study. Dose withholding occurred when Hb >13g/dL, and DA was restarted at 60% of previous dose once Hb ≤12g/dL. AEs of interest (hypertension, seizure, ischemic myocardial infarction, and embolism/thrombosis [arterial and venous]) were evaluated. Results: Over 700 pts (50% women) were enrolled. Previously it was reported that the QW and Q3W groups in this study had comparable efficacy (TFN rates from wk 5 to end of treatment, 30% and 23%, respectively), and 23.9% and 21.5%, respectively, reached Hb >13g/dL during the study. In this posthoc analysis, within each dose group and between each group, pts had similar rates of each AE of interest regardless of the maximum Hb achieved on study (Table). 43% in both groups reached Hb >12g/dL; mean (SD) number of QW visits Hb remained above 12g/dL was 5.2 (3.56) and 5.1 (3.89) visits, respectively. Pts with Hb ≤12g/dL had higher rates of death and TFN than those with Hb>12g/dL. Conclusions: Both DA regimens (2.25mcg/kg QW and 500mcg Q3W) were equally effective at preventing the need for TFN. Furthermore, control of Hb in both dose groups was similar as evidenced by the proportion of pts reaching a Hb >12 or 13g/dL. Finally, in this trial, regardless of DA regimen, pts with Hb >12g/dL did not exhibit greater rates of any AE of interest compared to those with Hb ≤12g/dL. Table. Outcomes by Maximum Hb on Study Outcomes Maximum Hb N = Number of pts evaluable; E = Total 16 person week exposure period; n = Number of pts experiencing event; r = Exposure adjusted pt incidence rate based on the number of pts with AEs in a 16-week time period (r=n/E). DA Dose Group ≤ 12g/dL >12g/dL Subjects / Exposure Time [N/E] 2.25μg/kg QW 202 / 177.5 150 / 154.5 500μg Q3W 200 / 177.7 153 / 159.3 Deaths [n(r)] 2.25μg/kg QW 43(0.24) 9(0.06) 500μg Q3W 31(0.17) 7(0.04) Transfusions [n(r)] 2.25μg/kg QW 96(0.54) 26(0.17) 500μg Q3W 85(0.48) 15(0.09) Hypertension [n(r)] 2.25 μg/kg QW 7(3.47) 6(4.00) 500μg Q3W 4(2.00) 4(2.61) Seizure [n(r)] 2.25μg/kg QW 0(0.00) 1(0.67) 500μg Q3W 1(0.50) 0(0.00) Ischemic myocardial infarction [n (r)] 2.25μg/kg QW 2(0.99) 1(0.67) 500μg Q3W 4(2.00) 1(0.65) Embolism/thrombosis (Arterial and Venous) [n (r)] 2.25μg/kg QW 17(8.42) 11(7.33) 500μg Q3W 16(8.00) 14(9.15)

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