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. 2021 Nov 15;2021(11):CD004293. doi: 10.1002/14651858.CD004293.pub4

Liang 2017.

Study characteristics
Methods

  • Study design: parallel, open‐label RCT

  • Study duration: January 2013 to April 2016

  • Duration of follow‐up: median observation period was 12 months (6 to 30 months)
Participants

  • Setting: single centre

  • Country: China

  • Inclusion criteria: aged 18 to 75 years; confirmed as the onset IMN by kidney biopsy in our centre; nephrotic syndrome, which was defined as urinary protein excretion of 3.5 g/24 hours, and serum albumin of 30 g/L; initial SCr level of < 133 µmol/L; no immunosuppressive agents used in the previous 6 months

  • Baseline characteristics

    • Mean SBP/DBP ± SD (mm Hg): treatment group 1 (124.3 ± 16.0 / 76.4 ± 11.9); treatment group 2 (129.9 ± 16.3 / 81.9 ± 13.2)

    • Mean proteinuria ± SD (g/24 hours): treatment group 1 (5.9 ± 2.7); treatment group 2 (6.9 ± 2.2)

    • Mean serum albumin ± SD (g/L): treatment group 1 (26.5 ± 6.2); treatment group 2 (24.1 ± 6.2)

    • Mean eGFR ± SD (mL/min/1.73 m²): treatment group 1 (93.6 ± 21.7); treatment group 2 (87.9 ± 24.9)

    • Mean triglyceride ± SD (mmol/L): treatment group 1 (2.7 ± 1.8); treatment group 2 (3.1 ± 2.3)

    • Mean SCr ± SD (µmol/L): treatment group 1 (70.7 ± 17.5); treatment group 2 (81.0 ± 22.5)

    • Mean serum cholesterol ± SD (mmol/L): treatment group 1 (7.5 ± 2.0); treatment group 2 (8.8 ± 3.0)

    • Disease‐course (time since diagnosis) at immunosuppressive treatment initiation: not reported

    • Pathological classification

      • Treatment group 1: stage 1 (20/30); stage 2 (9/30); stage 3 (1/30); stage 4 (0/30)

      • Treatment group 2: stage 1 (19/28); stage 2 (9/28); stage 3 (1/28); stage 4 (0/28)

    • Co‐morbidities: not reported

  • Number: treatment group 1(30); treatment group 2 (28)

  • Mean age ± SD (years): treatment group 1 (48.2 ± 13.5); treatment group 2 (53.9 ± 10.4)

  • Sex (M/F): treatment group 1(16/14); treatment group 1 (9/19)

  • Exclusion criteria: secondary membranous nephropathy, such as SLE; malignant tumour; infection, such as hepatitis B or C virus infection, tuberculosis, and syphilis; fasting blood glucose > 6.2 mmol/L; pregnancy or lactating; coexistence of life‐threatening complications, such as heart failure or active gastrointestinal bleeding
Interventions Treatment group 1

  • TAC: initial dose of 0.05 to 0.1 mg/kg/day divided into two doses at intervals of 12 hours without corticosteroids. The dose was adjusted according to the target trough blood concentration of 5 to 10 ng/mL for the first 6 months and reduced to 4 to 6 ng/mL for the subsequent 3 months. The dose was tapered gradually and discontinued at the end of 12 months. TAC dosage was to be reduced by 30% when a 30% increase in SCr is noted compared with the baseline value, and TAC was withdrawn if the kidney function was not improved after 2 weeks


Treatment group 2

  • CPA (IV): 0.5 to 0.75 g/m² once in every month for the initial 6 months and once in every 2 to 3 months for the later period. The accumulated dosage was 150 mg/kg

  • Prednisone (oral): 1 mg/kg/day for 4 weeks and tapered by 5 mg every 2 weeks to 30 mg/day and then reduced by 5 mg every 4 weeks until complete withdrawal at the end of 12 months


Co‐medications

  • Calcium‐channel blockers (5/58), beta‐receptor blockers (3/58) and diuretics (3/58) were prescribed in those patients who did not meet the target BP (< 125/75 mm Hg)

  • ACEi and ARB were not initiated during immunosuppressive therapy but were continued in patients who already received ACEi or ARB before recruitment (16/58)

  • Altiazem was used to elevate the concentration of TAC in blood

  • Anticoagulant drugs and statins were prescribed to all the patients
Outcomes

  • Complete remission: defined as a daily proteinuria level < 0.5 g with stable kidney function

  • Partial remission: defined as proteinuria of 0.5 to 3.5 g/day that was reduced no less than 50% of baseline levels with well‐preserved kidney function

  • Total remission: defined as either complete or partial remission

  • No remission: was defined as patients who did not achieve complete or partial remission criteria after 6 months of initial treatment

  • Relapse: defined as proteinuria >3.5 g/day in two consecutive urinalyses or a persistent severe hypoproteinaemia in patients who had achieved complete or partial remission

  • Changes in proteinuria

  • Changes in serum albumin

  • Changes in eGFR

  • Side effects
Notes

  • Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Not reported how random allocation was performed. Patients were able to switch their randomised intervention group after randomisation based on personal preferences, which some patients did
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk Not reported whether more were screened or allocated than were reported in the analysis however outcomes reported comprehensively
Selective reporting (reporting bias) Low risk Outcomes of interest reported
Other bias Low risk No evidence for other bias; no evidence for financial conflict of interest