Study characteristics |
Methods |
Study design: parallel, open‐label RCT
Study duration: not reported
Duration of follow‐up: 36 months
|
Participants |
Setting: not reported
Country: China
Inclusion criteria: biopsy‐proven IMN and nephritic syndrome; CD I & II; never had prednisolone or immunosuppression before
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Baseline characteristics
Mean proteinuria ± SD (g/24 hours): treatment group (9.57 ± 8.94); control group (9.42 ± 2.86)
Mean serum albumin ± SD (g/L): treatment group (23.4 ± 4.3); control group (23.5 ± 6.8)
Mean eGFR ± SD (mL/min/1.73 m²): treatment group (95.7 ± 21.6); control group (96.1 ± 17.8)
Mean SCr ± SD (µmol/L): treatment group (68.8 ± 20.2); control group (66.3 ± 15.7)
Mean serum cholesterol ± SD (mmol/L): treatment group (8.47 ± 3.17); control group (8.38 ± 2.56)
Disease‐course (time since diagnosis) at immunosuppressive treatment initiation: not reported
Pathological classification: not reported
Co‐morbidities: nephritic syndrome
Number: treatment group (13); control group (13)
Mean age ± SD (years): treatment group (43.1 ± 11.9); control group (42.7 ± 14.5)
Sex (M/F): treatment group (9/4); control group (8/5)
Exclusion criteria: secondary membranous nephropathy
|
Interventions |
Treatment group
Control group
Both groups
If worsening of IMN, then the maintenance of dose for 3 months before beginning the reduction. Initial dose of prednisone was 1 mg/kg/day in the morning and then gradually decreased in both groups
Co‐medications: not reported
|
Outcomes |
Follow‐up at 3, 12, 24 and 36 months |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Insufficient information to permit judgement. Groups are very similar in baseline characteristics, unlikely by chance. indicating some form of matching |
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 |
No evidence of attrition bias. all patients completed course of the study |
Selective reporting (reporting bias) |
Low risk |
No evidence of selective reporting. comprehensive reporting on all outcomes |
Other bias |
Low risk |
No evidence of other bias. authors declare no conflict of interest |