Abstract
BackgroundCombined treatment with cyclosporine microemulsion preconcentrate (CyA MEPC) and steroids has been widely used for idiopathic membranous nephropathy (IMN) associated with steroid-resistant nephrotic syndrome (SRNS). Recent studies have shown that once-a-day and preprandial administration of CyA MEPC is more advantageous than the conventional twice-a-day administration in achieving the target blood CyA concentration at 2 h post dose (C2). We designed a randomized trial to compare these administrations.MethodsIMN patients with SRNS (age 16–75 years) were divided prospectively and randomly into 2 groups. In group 1 (n = 23), 2–3 mg/kg body weight (BW) CyA MEPC was given orally once a day before breakfast. In group 2 (n = 25), 1.5 mg/kg BW CyA MEPC was given twice a day before meals. CyA + prednisolone was continued for 48 weeks.ResultsGroup 1 showed a significantly higher cumulative complete remission (CR) rate (p = 0.0282), but not when incomplete remission 1 (ICR1; urine protein 0.3–1.0 g/day) was added (p = 0.314). Because a C2 of 600 ng/mL was determined as the best cut-off point, groups 1 and 2 were further divided into subgroups A (C2 ≥600 ng/mL) and B (C2 <600 ng/mL). Groups 1A and 2A revealed significantly higher cumulative remission (CR + ICR1) (p = 0.0069) and CR-alone (p = 0.0028) rates. On the other hand, 3 patients with high CyA levels (C2 >900 ng/mL) in Group 1A were withdrawn from the study because of complications.ConclusionCyA + prednisolone treatment is effective for IMN with associated SRNS at a C2 of ≥600 ng/mL. To achieve remission, preprandial once-a-day administration of CyA at 2–3 mg/kg BW may be the most appropriate option. However, we should adjust the dosage of CyA by therapeutic drug monitoring to avoid complications.
Highlights
Idiopathic membranous nephropathy (IMN) is the most representative disease associated with steroid-resistant nephrotic syndrome (SRNS) in adults
Background Combined treatment with cyclosporine microemulsion preconcentrate (CyA MEPC) and steroids has been widely used for idiopathic membranous nephropathy (IMN) associated with steroid-resistant nephrotic syndrome (SRNS)
Recent studies have shown that once-a-day and preprandial administration of CyA MEPC is more advantageous than the conventional twice-a-day administration in achieving the target blood CyA concentration at 2 h post
Summary
Idiopathic membranous nephropathy (IMN) is the most representative disease associated with steroid-resistant nephrotic syndrome (SRNS) in adults. Cyclosporine (CyA), a calcineurin inhibitor, has been introduced as an effective agent for SRNS, and several randomized controlled trials (RCTs) on the combination of steroids and CyA showed significant remission rates [4,5,6]. Careful attention to the CyA concentration in blood is essential for the optimization of therapy [7]. Recent studies have shown that once-a-day administration is more advantageous than the conventional twice-aday administration, because the former provides an AP showing the peak blood concentration of CyA, which may facilitate the remission of SRNS and prevent chronic CyA nephrotoxicity [11, 12]. We designed a prospective, open-label randomized trial to compare the effect of preprandial oncea-day administration of CyA with that of conventional twice-a-day administration for IMN with associated SRNS. Blood CyA concentrations at C0 and C2 were evaluated during treatment
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
