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

Peng 2016.

Study characteristics
Methods

  • Study design; 3‐arm, parallel, open‐label RCT

  • Study duration; January 2009 to May 2013

  • Duration of follow‐up: 9 months
Participants

  • Setting: single centre

  • Country: China

  • Inclusion criteria: 18 to 75 years; diagnosis of IMN by renal biopsy and laboratory examination; persistent proteinuria (> 8 g/day) after observation for at least 1 month; nephrotic syndrome; not previously received any immunosuppressive treatment

  • Baseline characteristics

    • Mean SBP/DBP ± SD (mm Hg): treatment group 1 (122.3 ± 16.1 / 78.5 ± 10.5); treatment group 2 1(23.3 ± 14.0 / 77.7 ± 8.5); treatment group 3 (122.1 ± 12.6 / 80.2 ± 10.4)

    • Mean proteinuria ± SD (g/24 hours): treatment group 1 (11.7 ± 3.2); treatment group 2 (11.9 ± 1.5); treatment group 3 (12.1 ± 3.7)

    • Mean serum albumin ± SD (g/L): treatment group 1 (20.5 ± 3.4); treatment group 2 (19.8 ± 3.8); treatment group 3 (21.9 ± 4.9)

    • Mean eGFR ± SD (mL/min/1.73 m²): treatment group 1 (87.9 ± 16.5); treatment group 2 (97.3 ± 23.0); treatment group 3 (95.8 ± 24.9)

    • Mean triglyceride ± SD (mmol/L): treatment group 1 (3.3 ± 2.0); treatment group 2 (2.8 ± 1.2); treatment group 3 (2.9 ± 1.2)

    • Mean SCr ± SD (µmol/L): treatment group 1 (82.4 ± 13.6); treatment group 2 (78.4 ± 13.8); treatment group 3 (78.7 ± 13.8)

    • Mean serum cholesterol ± SD (mmol/L): treatment group 1 (10.4 ± 3.2); treatment group 2 (10.1 ± 2.6); treatment group 3 (9.8 ± 3.1)

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

    • Pathological stage: (I/II/III/IV): treatment group 1 (10/15/5/0); treatment group 2 (10/13/7/0); treatment group 3 (12/13/5/0)

    • Hypertension: treatment group 1 (8); treatment group 2 (7); treatment group 3 (5)

    • Antihypertensive agents were administered to achieve a target BP (systolic < 130 mm Hg and diastolic < 80 mm Hg) were not initiated during follow‐up, but were continued in patients who were already on such treatment prior to recruitment

  • Number (randomised/analysed): treatment group 1 (30/29); treatment group 2 (20/28); treatment group 3 (30/29)

  • Mean age ± SD (years): treatment group 1 (43.9 ± 13.2); treatment group 2 (40.8 ± 13.3); treatment group 3 (39.9 ± 14.3)

  • Sex (M/F): treatment group (17/13); treatment group 2 (16/14); treatment group 3 (14/16)

  • Exclusion criteria; SCr > 133 mmol/L; active infection; DM; autoimmune disease; tumours; liver function test abnormalities; active peptic ulcer disease
Interventions Treatment group 1

  • TAC (oral): 0.05 mg/kg/day divided into two doses at intervals of 12 hours initially. The dose was adjusted to achieve a blood trough concentration of 4 to 8 ng/mL for 6 months and then reduced to 2 to 4 ng/mL in the subsequent 3 months

  • Corticosteroid (oral): 0.5 mg/kg/day


Treatment group 2

  • CPA (IV): 750 mg/m² once a month for 6 months, which was then reduced to 750 mg/m² every 3 months

  • Corticosteroid (oral): 1 mg/kg/day for 2 months, which was reduced by 5 mg/day every 2 weeks to 20 mg/day. At that point, corticosteroid was tapered to zero according to the condition of the patient


Treatment group 3

  • MMF (oral): 1.5 to 2.0 g/day in 2 doses

  • Corticosteroid (oral): 1 mg/kg/day for 2 months, which was reduced by 5 mg/day every 2 weeks to 20 mg/day. At that point, corticosteroid was tapered to zero according to the condition of the patient


Duration of treatment

  • Nine months


Co‐interventions

  • Anticoagulant drugs and simvastatin were prescribed to all patients

  • ACEi/ARB: treatment group 1 (8); treatment group 2 (7); treatment group 3 (5) administered to achieve a target BP (SBP < 130 mm Hg and DBP < 80 mm Hg)
Outcomes

  • Remission

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

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

    • No response: proteinuria > 3.5 g/day or a value of 0.3 to 3.5 g/d, but with serum albumin < 30 g/L or an increase in the SCr greater than 50% above the baseline value

    • Relapse: proteinuria > 3.5 g/day in two consecutive measurements in patients with complete or partial remission, and not recovering within 2 weeks

  • Death

  • Relapse after partial response

  • Time to remission

  • Proteinuria

  • Serum albumin

  • SCr

  • > 30% increase in SCr

  • Adverse events
Notes

  • Funding sources:

    • National Basic Research Program of China

    • National Natural Science Foundation of China

    • Doctoral Program of Ministry of Education of China

    • Special Grade of China Postdoctoral Science Foundation

    • Heilongjiang Postdoctoral Science Research Foundation
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 1 lost to follow‐up, 2 died, 1 ceased due to leucopenia
Selective reporting (reporting bias) Low risk Data on primary outcome comprehensive, all outcomes reported data. intention‐to‐treat analysis was performed
Other bias Low risk No evidence for other sources of bias. no evidence for potential conflict of interest however, no study protocol was published beforehand