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. 2017 Feb 9;2(4):610-616.
doi: 10.1016/j.ekir.2017.02.004. eCollection 2017 Jul.

Two-Year Follow-up Study of Membranous Nephropathy Treated With Tacrolimus and Corticosteroids Versus Cyclical Corticosteroids and Cyclophosphamide

Raja Ramachandran  1 , Ashok Kumar Yadav  1 , Vinod Kumar  1 , Venkata Siva Tez Pinnamaneni  1 , Ritambhra Nada  2 , Ratan Ghosh  1 , Vivek Kumar  1 , Manish Rathi  1 , Harbir Singh Kohli  1 , Krishan Lal Gupta  1 , Vinay Sakhuja  1 , Vivekanand Jha  3   4
Affiliations

Two-Year Follow-up Study of Membranous Nephropathy Treated With Tacrolimus and Corticosteroids Versus Cyclical Corticosteroids and Cyclophosphamide

Raja Ramachandran et al. Kidney Int Rep. .

Abstract

Introduction: Both cCTX/GCs and CNIs are recommended as first-line agents in the management of PMN. The present study is an extended report of patients randomized to receive TAC/GCs or cCTX/GCs at 2 years post randomization.

Methods: Seventy patients enrolled in the clinical trial Tacrolimus Combined With Corticosteroids Versus Modified Ponticelli Regimen in Treatment of Idiopathic Membranous Nephropathy: Randomized Control Trial were followed quarterly between 12 and 24 months. At the end of 24 months, 3 patients were lost to follow-up.

Results: At 18 months, 66% and 89% (P = 0.04) were in remission in TAC/GCs and cCTX/GCs groups, respectively. At 18 and 24 months, 60% and 86% (P = 0.03) of cases were in remission in the TAC/GCs and cCTX/GCs groups, respectively. At 18 months, 57% and 83% (P = 0.03) of the patients in TAC/GCs and cCTX/GCs groups were in remission without need of any additional immunosuppression (persistent remission) and, at 24 months, 43% and 80% (P = 0.002) were in persistent remission in TAC/GCs and cCTX/GCs groups, respectively. Relapse rate after any remission was 40% and 6.7% in TAC/GCs and cCTX/GCs groups, respectively (P = 0.007). There was an association of aPLA2R titers with remission or resistance (P = 0.006) in relapsing PMN. The significant decrease in eGFR after 12 months of TAC/GCs therapy normalized at 18 and 24 months.

Discussion: At 2 years after randomization, relapse rates are higher for TAC/GCs compared with cCTX/GCs in PMN patients. Thus, cCTX/GCs are better than TAC/GCs in the longer term in PMN patients.

Keywords: PLA2R; cyclophosphamide; membranous nephropathy; randomized control trial; steroids; tacrolimus.

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Figures

Figure 1
Figure 1
Remission rate at various time points (1—intention to treat; 2—remission without any secondary immunosuppression). cCTX, cyclical cyclophosphamide; GCs, glucocorticoids; TAC, tacrolimus.
Figure 2
Figure 2
Graphical representation of proteinuria (right) and serum albumin (left) at various time intervals. The values are expressed as means and SDs (vertical lines). BL, baseline; cCTX, cyclical cyclophosphamide; GCs, glucocorticoids; TAC, tacrolimus.
Figure 3
Figure 3
Graphical representation of estimated glomerular filtration rate (eGFR) over various time points. The values are expressed as means and SDs (vertical lines). BL, baseline; cCTX, cyclical cyclophosphamide; GCs, glucocorticoids; TAC, tacrolimus.
See this image and copyright information in PMC

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