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

Li 2017c.

Study characteristics
Methods

  • Study design: parallel, open‐label RCT

  • Study duration: September 2015 to March 2016

  • Duration of follow‐up: 6 months
Participants

  • Setting: single centre

  • Country: China

  • Inclusion criteria: aged 18 to 60 years; IMN (stage I‐IV) proven by renal biopsy and laboratory examination; persistent proteinuria > 8 g/day; met diagnostic criteria for nephritic syndrome; SCr < 133 µmol/L

  • Baseline characteristics

    • Pathology stage (I/II/III/IV): treatment group 1 (1/11/4/0); treatment group 2 (3/11/1/0)

    • Hypertension: treatment group 1(3/16); treatment group 2 (4/15)

    • Mean SBP/DBP ± SD (mm Hg): treatment group 1 (133.1 ± 15.0 / 87.1 ± 9.2); treatment group 2 (125.2 ± 13.8 / 83.4 ± 8.2)

    • Mean proteinuria ± SD (g/24 hours): treatment group 1 (9.5 ± 1.9); treatment group 2 (9.7 ± 2.5)

    • Mean serum albumin ± SD (g/L): treatment group 1 (22.8 ± 3.8); treatment group 2 (23.2 ± 5.8)

    • Mean total cholesterol ± SD (mmol/L): treatment group 1 8.0 ± 3.2); treatment group 2 (9.1 ± 3.1)

    • Mean triglycerides ± SD (mmol/L): treatment group 13.1 ± 2.2); treatment group 2 (2.3 ± 1.3)

    • Mean SCr ± SD (µmol/L): treatment group 1 71.8 ± 17.4); treatment group 2 73.3 ± 16.5)

  • Number: treatment group 1 (16); treatment group 2 (15)

  • Mean age (years): treatment group 1 (39.4); treatment group 2 (42.8)

  • Sex (M/F): treatment group 1 (12/4); treatment group 2 (13/2)

  • Exclusion criteria: serious complications such as thromboembolism, kidney failure or infection; serious diseases companied such as HIV, cardiac dysfunction, hepatitis B, hepatitis C or liver function test abnormalities, DM, and other kidney diseases; received any cytotoxic drugs and immunosuppressant treatment in the past; pregnant or lactating women; poor adherence to the drug
Interventions Treatment group 1

  • TAC: 0.05 to 0.1 mg/kg/day divided into 2 equal doses at 12‐hour intervals. The drug concentration was first checked after 1 week and dosage according to the whole blood concentration, with a target of 5 to 10 ng/mL


Treatment group 2

  • CSA: 3 to 5 mg/kg/day divided into 2 equal doses at 12‐hour intervals. The dose was adjusted to achieve a blood trough concentration of 100 to 200 ng/mL. Lower blood trough concentration levels of TAC or CSA were accepted if patients were in remission


Co‐interventions

  • Both groups received oral prednisone at a dose of 0.5 mg/kg/day. This dose was tapered by 5 mg/month down to 10 mg/day and maintained that dosage throughout the remainder of the 6‐month therapy period

  • Antihypertensive agents were administered to achieve a target BP (SBP < 125 mm Hg and DBP < 75 mm Hg). ARB or ACEI and other antihypertensive drugs were prescribed in those patients who did not reach the above target values

  • Participants with serum cholesterol > 5.6 mmol/L were treated with rosuvastatin

  • Anticoagulant drugs, calcium carbonate and vitamin D were also prescribed to all the patients
Outcomes

  • Complete remission: daily proteinuria < 0.3 g, normal serum albumin (≥ 35 g/L), and stable kidney function

  • Partial remission: proteinuria of 0.3 to 3.5 g/day that had declined to ≤ 50% of the baseline value with a serum albumin concentration of at least 30 g/L and a stable kidney function

  • No response: proteinuria ≥ 3.5 g/day and decease < 50% of the baseline value

  • Adverse events
Notes

  • Funding source

    • National Natural Science Foundation of China (81300605)

    • Major Medical Science and Technology Program Plan of Henan Province (201501010)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk According to a randomisation list generated from the table of random numbers
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 All patients completed the study
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk Study appears free of other biases