| Study characteristics |
| Methods |
Study design: parallel, open‐label RCT Study duration: March 2012 to January 2016 Duration of follow‐up: 24 months for both groups |
| Participants |
Setting: multicentre Country: China Inclusion criteria: pathologically diagnosed with IMN at stage I‐III based on the KDIGO Clinical Practice Guidelines; SCr < 221 μmol/L; pregnancy‐bearing female patients with negative pregnancy test results, who agreed to take contraceptive measures Baseline characteristics: not reported Number (randomised/analysed): treatment group 1 (37/35); treatment group 2 (39/35) Mean age ± SD (years): treatment group 1 (47.9 ± 17.1); treatment group 2 (46.9 ± 15.4) Sex (M/F): treatment group 1 (22/13); treatment group 2 (20/15) Exclusion criteria: infections; malignant tumours; tuberculosis or other serious kidney diseases; administered corticosteroids or other immunosuppressive agents within the last month; abnormal liver function, or type 1 or 2 DM; allergic to macrolide drugs |
| Interventions |
Treatment group 1
Treatment group 2
Treatment details
Patients in both groups were administered low‐dose prednisone (0.5 mg/kg/day) combined with TAC (0.1 mg/kg/day) orally for routine treatment. At 8 weeks following initial administration, the dose of prednisone was reduced by 5 mg every 4 weeks and then maintained at a total of 10 mg/day. The short‐course treatment group received TAC (0.1 mg/kg/day) once every 12 h; patients were administered the drug orally when fasting (0.5 h prior to meals). Following 1 week of treatment, the plasma concentration of TAC was monitored and if the concentration was < 5 μg/L, the dosage of TAC was increased until the plasma concentration was maintained at 5 to 10 μg/L. This cut off value was based on a previous study. At 6 months of treatment, the plasma concentration of TAC was maintained at 2 to 4 μg/L and patients continued treatment until the 12‐month period ended. The long‐course group were administered the same treatment as the short‐course group. At 6 months following treatment, TAC plasma concentration was maintained at 2 to 4 μg/L and patients continued to receive this dosage until the 24‐month treatment period had ended
|
| Outcomes |
Complete remission: urinary protein < 0.3 g, normal serum albumin levels and normal kidney function Partial remission: urinary protein was 0.3 to 3.0 g, or when its basal value was reduced by > 50%. In addition, serum albumin had to be ≥ 30 g/L with stable kidney function No remission: considered when the efficacy did not reach the criteria for partial remission Recurrence was determined after the efficacy reached complete or partial remission, but symptoms in line with the diagnostic criteria for nephrotic syndrome recurred in the course of administration. The repeated occurrence occurred when the efficacy reached partial remission, but various incentives led to elevated levels of urinary protein, which did not meet the diagnostic criteria for nephrotic syndromes |
| Notes |
Funding: no funding was received Ethics: The protocol was approved by the Ethics Committee of the First People's Hospital of Changzhou. Written, informed consent was obtained from all participants prior to enrolment Declarations of Interests/disclosures: reported no conflict of Interest Trial registration or Protocol registration or publication: 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 |
No evidence of incomplete data. Comprehensive reporting. Low‐drop‐out rate (all due to severe adverse effects, which are reported) |
| Selective reporting (reporting bias) |
High risk |
No protocol reported, not all kidney outcomes reported |
| Other bias |
Low risk |
Conflict of Interest of authors not declared. Sources of Funding declared (public funding). No evidence of other bias |
