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

Li 2015.

Study characteristics
Methods
  • Study design: parallel, open‐label RCT

  • Study duration: January 2008 to January 2013

  • Duration of follow‐up: 6 to 48 months; mean duration was 13.5 ± 6.2 months

Participants
  • Setting: single centre

  • Country: China

  • Age: 65‐81 years

  • Sex: 15 men, 12 women

  • Inclusion criteria: IMN confirmed by biopsy examined using light microscopy, immunofluorescence, and electron microscopy, and the condition of the patients was pathologically diagnosed as IMN stage I and II; 24‐hour protein levels > 4 g; > 65 years

  • Baseline characteristics

    • Mean proteinuria ± SD (g/24 hours): treatment group (7.5 ± 3.8); control group (7.2 ± 3.4)

    • Mean eGFR ± SD (mL/min/1.73 m²): treatment group (70.9 ± 11.9); control group (69.6 ± 10.3)

    • Mean triglyceride ± SD (mmol/L): not reported

    • SCr (µmol/L): treatment group (91.6 ± 20.9); control group (98.8 ± 15.1)

    • Mean serum cholesterol ± SD (mmol/L): not reported

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

    • Pathological classification: stage I or stage 2

    • Co‐morbidities: not reported

    • Co‐medications: all patients received lipid‐lowering drugs and anti‐platelet adhesion drugs. BP was controlled to target < 140/90 mm Hg

  • Number: treatment group (13); control group (14)

  • Mean age (years): treatment group (74.8): control group (75.1)

  • Sex (M/F) 15/12: treatment group (10/3); control group (10/4)

  • Exclusion criteria: secondary membranous nephropathy induced by secondary factors such as autoimmune diseases, cancer, infections and drugs, or atypical membranous nephropathy; HIV infection; diagnosed with malignant tumour infection; active hepatitis B or C or with positive replication indexes

Interventions Treatment group
  • CSA (oral) initial dose was 2 mg/kg/day and the treatment duration was not less than 6 months

  • Methylprednisolone (oral): initial dose was 0.4 mg/kg/day which gradually decreased after 8 to 12 weeks administration; the total duration of treatment was 6 to 12 months


Control group
  • Low‐dose CSA

Outcomes
  • Clinical remission rate: complete + partial remission / total number of patients x 100%

  • Complete remission: defined as urinary protein level ≤ 0.3 g/day, serum albumin level > 35 g/L, stable kidney function (increase in the SCr < 15% of the baseline value)

  • Partial remission: defined as the decrease in urinary protein level by more than 50% of the baseline value, urinary protein level ≤ 3.5 g/day, stable kidney function

  • No remission: defined as the decrease in the urinary protein level less than 50% of the baseline value, or the urinary protein level was > 3.5 g/day or the SCr > 50% of the baseline value

  • Safety

    • Adverse reactions observed during the treatment were infection, osteonecrosis, steroid glycosuria, and hepatonephritic toxicity, and patients discontinued treatment

    • Complications were steroid diabetes

    • Hypertension (uncontrollable)

    • Infection

    • SCr increase > 50%

    • Recurrence rate after drug withdrawal

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
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 Reasonable and comprehensive outcome reporting. Unable to determine if more were randomised than reported
Selective reporting (reporting bias) Low risk Reports on remissions, most appropriate outcome. All outcomes were reported
Other bias Low risk No evidence for other bias. no evidence for conflict of interest, however, no trial protocol published